Prophylactic antiemetic therapy with granisetron-dexamethasone combination in women undergoing breast surgery

Background: Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. This study was undertaken to evaluate the efficacy of granisetron-dexamethasone combination for the prevention of postoperative nausea and vomiting (PONV) in female patients undergoing general anaesthesia for breast surgery.
Methods: In a randomized, double-blind manner, 135 ASA I patients, aged 40–65 years, were assigned to receive placebo (saline), granisetron 40 μg · kg⁻¹ or granisetron 40 μg · kg⁻¹ plus dexamethasone 8 mg i.v. (n=45 of each) immediately before the induction of anaesthesia. A standard general anaesthetic technique and postoperative analgesia were used. The PONV and safety assessments were performed continuously during the first 3 h (0–3 h) and the next 21 h (3–24 h) after anaesthesia.
Results: A complete response, defined as no PONV and no administration of rescue antiemetic medication, during 0–3 h after anaesthesia was 51%, 82% and 96% in patients who had received placebo, granisetron and granisetron-dexamethasone combination, respectively; the corresponding incidence during 3–24 h after anaesthesia was 56%, 84% and 98% ( P <0.05; overall Fisher's exact probability test). No clinically important adverse events were observed in any of the groups.
Conclusion: Prophylactic use of granisetron-dexamethasone combination is more effective than granisetron alone for the prevention of PONV after breast surgery.     

Prevention of nausea and vomiting in female patients undergoing breast surgery: A comparison with granisetron, droperidol, metoclopramide and placebo

Background : Breast surgery is associated with a relatively high incidence of postoperative nausea and vomiting (PONV). This study was undertaken to evaluate the efficacy of granisetron, droperidol and metoclopramide for preventing PONV after breast surgery.
Methods : In a randomized, double-blind, placebo-controlled trial, 120 female patients received granisetron 40μg.kg^-1, droperidol 1.25 mg, metoclopramide 10 mg or placebo (saline) (n=30 for each) intravenously immediately before the induction of anaesthesia. A standard general anaesthetic technique was employed throughout. Postoperatively, during the first 24 h after anaesthesia, the incidence of PONV and adverse events was recorded.
Results : The incidence of PONV was 17% with granisetron, 37% with droperidol, 43% with metoclopramide and 50% with placebo ( P <0.05; overall Fisher's exact probability test). The incidence of adverse events was not different among the groups.
Conclusion : Granisetron is highly effective for reducing the incidence of PONV in female patients undergoing breast surgery. Droperidol and metoclopramide are ineffective in this population.     

Preoperative oral granisetron prevents postoperative nausea and vomiting

Background: Postoperative nausea and vomiting (PONV) is a commonly observed adverse effect of anaesthesia. This study was designed to evaluate the efficacy of granisetron administered orally for preventing PONV in female patients undergoing major gynaecological surgery.
Methods: In a prospective, randomized, placebo-controlled, double-blind study, 120 patients received orally either placebo or granisetron (1 mg, 2 mg or 4 mg) (n=30 for each) 1 h before surgery. The same standard general plus regional anaesthetic technique was employed throughout. Postoperatively, during the first 24 h after anaesthesia, the incidence of PONV and adverse events was recorded by nursing staff.
Results: The incidence of PONV was 47% with placebo, 37% with granisetron 1 mg, 10% with granisetron 2 mg and 10% with granisetron 4 mg (P<0.05; overall Fisher's exact probability test). No difference in the incidence of adverse events was observed among the groups.
Conclusion: Preoperative oral granisetron in a minimum dose of 2 mg is effective for preventing PONV after major gynaecological surgery.     

Effective dose of granisetron in the reduction of nausea and vomiting after breast surgery

Background: Prophylactic use of granisetron, a selective Shydroxytryptamine type 3 receptor antagonist, reduces the incidence of nausea and vomiting after breast surgery. This study was undertaken to determine the minimum effective dose of granisetron in the reduction of postoperative nausea and vomiting (PONV) in patients undergoing general anaesthesia for breast surgery.
Methods: In a randomized, double-blind manner, 120 female patients aged 42–66 years were assigned to receive either placebo (saline) or granisetron in a dose of 20 μg · kg^-1, 40 μg · kg^-1 and 80 μg · kg^-1 i.v. immediately before the induction of anaesthesia. A standard general anaesthetic technique was employed throughout. The POW and safety assessments were performed continuously during the first 24 h after anaesthesia.
Results: There were no significant differences among the groups with regard to patient demographics, surgical procedures, anaesthetics administered and analgesics given. The incidence of PONV was 47%, 43%, 17% and 17% after administration of placebo and granisetron 20 μg -kg^-1, 40 μg kg^-1 and 80 μg kg^-1, respectively. Granisetron 40 μg kg^-1 was as effective as 80 μ g - kg^-1 and both resulted in significant reductions of the incidence of PONV compared with placebo and granisetron 20 μg kg^-1 ( P < 0.05). No differences in the incidence of adverse events were observed among the groups.
Conclusion: Granisetron 40 μg · kg^-1 appears to be the minimum effective dose for reducing POW in patients undergoing general anaesthesia for breast surgery.     

Prophylactic antiemetic efficacy of granisetron or ramosetron in patients undergoing thyroidectomy

OBJECTIVE: Thyroidectomy is associated with a high incidence of postoperative nausea and vomiting (PONV), ranging from 60% to 84%. We conducted this study to compare the antiemetic effects and safety of granisetron 20 micro g/kg and ramosetron 4 micro g/kg in patients undergoing elective thyroidectomy under standard anaesthetic technique. METHODS: One hundred and thirteen patients were randomized to receive placebo (n = 41), granisetron 20 nug/kg (n = 36) or ramosetron 4 micro g/kg (n = 36) intravenously over 2-5 minutes immediately before the induction of anaesthesia. The incidence of PONV, nausea severity score (NSS), adverse events and the need for rescue antiemetics were assessed during the first 1 hour (0-1 h) and following 23 hours (1-24 h) after anaesthesia. RESULTS: During the first hour after anaesthesia, the incidence of PONV was 36.6% for placebo, 11.1% for granisetron (p = 0.012 vs placebo) and 25.0% for ramosetron. During 1 hour to 23 hours after anaesthesia, the incidence of PONV was 51.2% for placebo, 30.6% for granisetron and 41.7% for ramosetron. There were no significant differences between the three groups. Overall (0-24 h), the corresponding incidence of PONV were 61.0%, 30.6% and 50.0%, respectively, showing a significantly lower value in the granisetron group than in the placebo group (p = 0.008). The incidence of vomiting and rescue antiemetic requirement during the first 24 hours after anaesthesia was significantly lower with the granisetron group than with placebo (p = 0.021 and 0.030, respectively). The most common adverse events in the three groups were headache and dizziness. CONCLUSION: Only granisetron 20 micro g/kg was superior to placebo for the prevention of PONV after thyroidectomy.     

Granisetron-droperidol combination for the prevention of postoperative nausea and vomiting in female patients undergoing breast surgery

We have compared the efficacy and safety of the combination granisetron- droperidol with each antiemetic alone in preventing postoperative nausea and vomiting (PONV) after breast surgery. In a randomized, double-blind study, 150 female patients received granisetron 3 mg, droperidol 1.25 mg or granisetron 3 mg with droperidol 1.25 mg (n = 50 each) i.v., immediately before induction of anaesthesia. A standard general anaesthetic technique was used. The incidence of PONV during the first 24 h after anaesthesia was 18% with granisetron, 38% with droperidol and 4% with the granisetron-droperidol combination (P < 0.05; overall Fisher's exact probability test). We conclude that the granisetron-droperidol combination was more effective than each antiemetic alone in the prevention of PONV in female patients undergoing breast surgery.      

Prophylactic antiemetic therapy with granisetron in women undergoing thyroidectomy

We have evaluated the efficacy and safety of granisetron, a selective 5- hydroxytryptamine type-3 receptor antagonist, for the prevention of postoperative nausea and vomiting (PONV) in women undergoing thyroidectomy. In a prospective, randomized, placebo-controlled, double- blind study, 100 ASA I patients, aged 30-57 yr, received placebo or granisetron at three different doses (20, 40 or 100 micrograms kg-1) (n = 25 each), i.v., immediately before induction of anaesthesia. A standard general anaesthetic technique was used. A complete response, defined as no PONV and no need for another rescue antiemetic during the first 3 h after anaesthesia, was seen in 36%, 44%, 92% and 92% of patients who received placebo, granisetron 20 micrograms kg-1, 40 micrograms kg-1 and 100 micrograms kg-1, respectively; corresponding values during the next 21 h after anaesthesia were 40%, 44%, 88%, and 88% (P < 0.05; overall Fisher's exact probability test). There were no clinically important adverse events in any group. We conclude that granisetron 40 micrograms kg-1 was an effective antiemetic for the prevention of PONV after thyroidectomy. Increasing the dose to 100 micrograms kg-1 provided no further benefit.      

Prevention of postoperative nausea and vomiting in female patients during menstruation: comparison of droperidol, metoclopramide and granisetron

The incidence of postoperative nausea and vomiting (PONV) is high in women during menstruation. We have compared the efficacy of droperidol, metoclopramide and granisetron in the prevention of PONV in female patients during menstruation undergoing major gynaecological surgery. In a randomized, double-blind study, 120 patients received droperidol 25 micrograms kg-1, metoclopramide 0.2 mg kg-1 or granisetron 40 micrograms kg-1 (n = 40 in each group) i.v. immediately before induction of anaesthesia. A standard general anaesthetic technique and postoperative analgesia were used throughout. There was a complete response, defined as no PONV and no administration of rescue medication, during the 24-h observation period in 45% of patients in the droperidol group, 38% in the metoclopramide group and 70% in the granisetron group (P = 0.021 vs droperidol, P = 0.003 vs metoclopramide). There was no difference in the incidence of adverse events between groups. We conclude that the prophylactic antiemetic efficacy of granisetron was superior to that of droperidol or metoclopramide for prevention of PONV in women during menstruation.      

RETRACTED ARTICLE: Prophylactic antiemetic efficacy of granisetron in patients with and without previous postoperative emesis

Purpose

To evaluate the efficacy of granisetron, a selective antagonist of 5-hydroxytryptamine type 3 receptors. in the prevention of PONV in patients with and without previous postoperative emesis undergoing general anaesthesia for major gynaecological surgery.

Methods

In a randomized, double-blind, placebo-controlled trial of 90 women with (n=40) and without (n = 50) a history of PONV the patients received either granisetron (40 μg·kg^?1) or placebo (saline)iv immediately before induction of anaesthesia. The same standard general anaesthetic technique, which consisted of isoflurane in nitrous oxide and oxygen and avoided opioids, was used. Nausea, vomiting and safety assessments were performed during the first 24 hr after anaesthesia.

Results

The incidence of PONV was 70% and 25% after administration of placebo and granisetron in patients with previous PONV (P < 0.05), and was 40% and 8% in patients without it, respectively (P < 0.05). The incidence of adverse events postoperatively were not different among the treatment groups.

Conclusion

Granisetron 40 μg·kg given prior to anaesthesia reduces the incidence of PONV in patients with a history of PONV as well as in patients without it.     

RETRACTED ARTICLE: Prevention of PONV with granisetron, droperidol and metoclopramide in female patients with history of motion sickness

Purpose

Motion sickness is one of the patient-related factors associated with postoperative nausea and vomiting (PONV). This study was undertaken to assess the efficacy of granisetron, droperidol and metoclopramide for preventing PONV in female patients with a history of motion sickness undergoing major gynaecological surgery.

Methods

In a prospective, randomized, placebo-controlled, double-blind study. 120 patients received either 1.25 mg dropendol. 10 mg metoclopramide, 40 μkg granisetron or placebo (saline)iv immediately before induction of anaesthesia. A standardized anaesthetic technique and postoperative analgesia were used in all patients. During the first 24 hr after anaesthesia, the incidence of PONV and adverse events were recorded by nursing-staff.

Results

The treatment groups were similar for patient demographics, types of surgery, anaesthetics administered and opioid given. The incidence of PONV was 70%, 50%. 57% and 23% in the placebo, droperidol, metoclopramide and granisetron groups, respectively (P < 0.05; overall χ² test). No difference in the incidence of adverse events was observed in either group.

Conclusion

Granisetron is a better prophylactic antiemetic than dropendol or metoclopramide in female patients with a history of motion sickness undergoing major gynaecological surgery.     

Granisetron and ondansetron for prevention of nausea and vomiting in patients undergoing modified radical mastectomy

Modified radical mastectomy is associated with a relatively high incidence of postoperative nausea and vomiting (PONV). This study was undertaken to evaluate the comparative profile and efficacy of ondansetron and granisetron to prevent PONV after modified radical mastectomy. In a randomized, double-blind, placebo-controlled trial, sixty female patients received ondansetron 4 mg, granisetron 1 mg or saline intravenously just before induction of anaesthesia (n = 20 for each group). A standardized general anaesthetic technique was employed. The incidence of PONV and adverse events were recorded for the first 24h postoperatively. The incidence of PONV was 25% with ondansetron, 20% with granisetron and 70% with saline (P < 0.05, Chi-square test with Yates' correction factor). The incidence of adverse events was comparable among the groups. Ondansetron and granisetron are both effective for reducing the incidence of PONV in female patients undergoing modified radical mastectomy.     

Granisetron/dexamethasone combination for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. This study was undertaken to evaluate the efficacy of granisetron/dexamethasone combination for preventing postoperative nausea and vomiting (PONV) after lapIaroscopic cholecystectomy (LC). In a prospective, randomized, double-blind manner, 120 patients (83 females), aged 25-65 years, were assigned to receive granisetron 40 microg kg-1 alone or granisetron 40 microg kg-1 plus dexamethasone 8 mg (n=60 of each) intravenously immediately before the induction of anaesthesia. A standardized general anaesthetic procedure and postoperative analgesia were used. A complete response, defined as no PONV and no need for another rescue antiemetic, during 0-3 h after anaesthesia was 83% with granisetron and 98% with granisetron plus dexamethasone, respectively (P=0.008); the corresponding incidence during 3-24 h after anaesthesia was 83% and 98% (P=0.008). No clinically important adverse events were observed in any of the group. In conclusion, prophylactic therapy with granisetron/dexamethasone combination is more effective than granisetron alone for the prevention of PONV after LC.     

Granisetron in the prevention of nausea and vomiting after middle-ear surgery: a dose-ranging study

This study was undertaken to determine the minimum effective dose of granisetron, a selective 5-hydroxytryptamine type 3 receptor antagonist, for the prevention of postoperative nausea and vomiting (PONV) after middle-ear surgery. In a randomized, double-blind, placebo- controlled trial, 120 women (ASA I) received placebo (saline) or granisetron at three different doses (20 micrograms kg-1, 40 micrograms kg-1, 100 micrograms kg-1) i.v. immediately before the induction of anaesthesia (n = 30 for each group). A standard general anaesthetic technique was used throughout. A complete response, defined as no PONV and no need for another rescue antiemetic during 0-3 h after anaesthesia, occurred in 40%, 43%, 83% and 87% of patients who had received placebo, granisetron 20 micrograms kg-1, granisetron 40 micrograms kg-1 or granisetron 100 micrograms kg-1, respectively; the corresponding incidence during 3-21 h after anaesthesia was 47%, 47%, 87% and 87% (P < 0.05; overall Fisher's exact probability test). Granisetron 40 micrograms kg-1 appears to be the minimum effective dose for preventing PONV in women undergoing middle-ear surgery.      

Prophylactic antiemetic therapy with ondansetron,tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized,double-blind comparison with placebo

Purpose

Postoperative nausea and vomiting (PONV) is a distressing adverse effect of general anaesthesia. The aim of the current study was to compare the antiemetic activity of different 5-hydroxytryptamine₃ receptor antagonists with that of metoclopramide and placebo.

Methods

In a prospective, randomized, double-blind study we have compared the antiemetic activity of the prophylactic administration of ondansetron 4 mg, tropisetron 5 mg and granisetron 3 mg with that of metoclopramide 10 mg and placebo in 132 patients undergoing laparoscopic cholecystectomy. All study drugs and placebo were given as a short iv infusion ten minutes before the induction of anaesthesia. Perioperative anaesthetic care was standardized in all patients. Nausea and vomiting were assessed by direct questioning of the patient at 1, 4, 9, 12, 18 and 24 hr after recovery from anaesthesia. If patients experienced nausea and/or vomiting, rescue antiemetic treatment (metoclopramide 10 mg iv) was administered.

Results

For the 24-hr recovery period after surgery, the percentages of emesis-free patients were 65.5%, 52%, 48%, 29.2% and 27.6% in the ondansetron, granisetron, tropisetron, metoclopramide and placebo groups, respectively. Prophylactic antiemetic treatment with ondansetron resulted in a lower incidence (P = 0.02) of PONV than with metoclopramide or placebo. The times at which rescue antiemetic was first received were longer (P < 0.01) in ondansetron group than in the placebo and metoclopramide groups. There were no statistical differences between ondansetron, tropisetron and granisetron groups.

Conclusions

Ondansetron, when given prophylactically resulted in a significantly lower incidence of PONV than metoclopramide and placebo. Metoclopramide was ineffective.     

Granisetron reduces the incidence of nausea and vomiting after middle ear surgery

We studied the efficacy of granisetron, a selective 5-hydroxytryptamine type-3 receptor antagonist, in preventing postoperative nausea and vomiting (PONV) after middle ear surgery. In a randomized, double- blind, placebo-controlled study, 60 ASA I patients received placebo (saline) or granisetron 40 micrograms kg-1 i.v. immediately before induction of anaesthesia (n = 30 in each group). A standard general anaesthetic technique was used. During the first 24 h after anaesthesia, the incidence of PONV in patients who had received granisetron was lower than in those who had received placebo (17% vs 63%; P < 0.05). There were no clinically important adverse effects in either group. We conclude that granisetron, given before anaesthesia, reduced the incidence of PONV after middle ear surgery.      

Prevention of nausea and vomiting with granisetron, droperidol and metoclopramide during and after spinal anaesthesia for caesarean section: A randomized, double-blind, placebo-controlled trial

Background: Nausea and vomiting during and after spinal anaesthesia for caesarean section are distressing to the patient. This study was undertaken to evaluate the efficacy and safety of granisetron, droperidol and metoclopramide for the prevention of nausea and vomiting in parturients undergoing caesarean section under spinal anaesthesia.
Methods: In a randomized, double-blind, placebo-controlled trial, 120 patients received granisetron 3 mg, droperidol 1.25 mg, metoclopramide 10 mg or placebo (saline) ( n =30 of each) i. v. immediately after clamping of the foetal umbilical cord. Nausea, vomiting and safety assessments were performed during and after spinal anaesthesia for caesarean section.
Results: The incidence of intraoperative, post-delivery nausea and vomiting was 13%, 17%, 20% and 63% after administration of granisetron, droperidol, metoclopramide and placebo, respectively; the corresponding incidence during 0–3 h after surgery was 7%, 27%, 27% and 43%; the corresponding incidence during 3–24 h after surgery was 7%, 20%, 23% and 37% ( P <0.05; overall Fisher's exact probability test). No clinically important adverse events were observed in any of the groups.
Conclusion: Granisetron is highly effective for preventing nausea and vomiting during and after spinal anaesthesia for caesarean section. Droperidol and metoclopramide are effective for the prevention of intraoperative, post-delivery emesis, but are ineffective for the reduction of the incidence of postoperative emesis.     

Preoperative oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery.

OBJECTIVE: To evaluate the efficacy and safety of oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery. DESIGN: Prospective, randomised, double-blind, placebo-controlled study. SETTING: University affiliated hospital, Japan. SUBJECTS: 100 women listed for partial or modified radical mastectomy with or without axillary dissection. INTERVENTIONS: Patients were given either placebo or granisetron in three different doses (1 mg, 2 mg, 4 mg) orally 1 hour preoperatively (n = 25 in each group). A standard general anaesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: All episodes of nausea and vomiting during the first 24 hours after anaesthesia. RESULTS: Complete response, defined as no nausea and vomiting and no need for a "rescue" antiemetic, during the first 24 hours after anaesthesia was recorded in 13 (52%) with placebo, 14 (56%) with granisetron 1 mg, 22 (88%) with 2 mg, and 22 (88%) with 4 mg, respectively (p = 0.006, Fisher's exact test). No clinically serious adverse events were seen in any of the groups. CONCLUSION: Preoperative oral granisetron, in doses of more than 2 mg, is effective for the prevention of postoperative nausea and vomiting in women undergoing general anaesthesia for breast surgery.     

Granisetron/dexamethasone combination for the prevention of postoperative nausea and vomiting after thyroidectomy

This study was undertaken to evaluate the efficacy of granisetron plus dexamethasone for preventing postoperative nausea and vomiting (PONV) after thyroidectomy. In a prospective, randomized, double-blind study, 130 female patients received either granisetron 40 micrograms/kg or granisetron 40 micrograms/kg plus dexamethasone 8 mg intravenously immediately before the induction of anaesthesia (n = 65 in each group). A standard general anaesthetic technique was used. A complete response (no PONV, no rescue) during the first three hours after anaesthesia occurred in 85% of patients with granisetron alone and 98% with granisetron plus dexamethasone; the corresponding incidence for the period 3 to 24 hours after anaesthesia was 86% and 98% (P < 0.05; Fisher's exact probability test). No clinically serious adverse events were observed in any of the groups. In conclusion, prophylactic use of granisetron/dexamethasone combination is more effective than granisetron alone for preventing PONV in women undergoing thyroidectomy.     

RETRACTED ARTICLE: Granisetron reduces the incidence and severity of nausea and vomiting after laparoscopic cholecystectomy

Purpose

Postoperative nausea and vomiting (PONV) are commonly observed undesirable consequences of laparoscopic cholecystectomy. This study was undertaken to compare granisetron, a selective 5-hydroxytryptamine type 3 receptor antagonist, with dropendol for reducing the incidence and seventy of PONV after laparoscopic cholecystectomy.

Methods

Eighty patients, aged 25–65 yr. scheduled for elective laparoscopic cholecystectomy were enrolled in a randomized, double-blinded investigation and assigned to one of three treatment regimens: placebo (saline), 1.25 mg dropendol (approximately 25μg·kg^?1) or 3 mg granisetron (approximately 60μg·kg^?1). The study drugs were administerediv immediately before the induction of anaesthesia. A standard general anaesthetic technique was employed throughout. Nausea, vomiting and safety assessments were performed continuously dunng the first 24 hr after anaesthesia.

Results

The incidence of PONV was 46% with placebo, 41 % with dropendol and 15% with granisetron (P< 0.05; overall C² test). Four patients who had received placebo and two who had received dropendol required another rescue antiemetic, compared with none who had received granisetron (P< 0.05). Adverse events postoperatively were not different among the groups.

Conclusion

Granisetron is more effective than dropendol and placebo for reducing the incidence and seventy of PONV after laparoscopic cholecystectomy.     

Prophylactic therapy with granisetron in the prevention of vomiting after paediatric surgery. A randomized, double-blind comparison with droperidol and metoclopramide

The antiemetic efficacy of droperidol, metoclopramide and granisetron was compared with placebo in the reduction of vomiting after paediatric surgery (the extremities; inguinal hernia; and phimosis) during general inhalational anaesthesia. One hundred children, ASA physical status I, 4–10 years of age, were enrolled in a prospectively, randomized, double-blind investigation and assigned to one of four treatment regimens: placebo (saline, n=25), droperidol (50 μg·kg¹, n=25), metoclopramide (0.25 mg·kg-¹, n=25) or granisetron (40 μg·kg^-1, n=25). These drugs were administered intravenously (iv) after inhalation induction of anaesthesia. A complete response, defined as no emesis and no need for another rescue antiemetic during the first 24 h after anaesthesia, occurred in 60%, 76%, 68% and 88% of patients who had received placebo, droperidol, metoclopramide and granisetron, respectively (P<0.05; overall Fisher's exact probability test). The incidence of adverse events postoperatively was not different among the treatment groups. In conclusion, granisetron 40 μg·kg^-1 is a better antiemetic than droperidol and metoclopramide when compared to placebo for the prevention of postoperative emesis in children.