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.     

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.      

Prophylactic antiemetic therapy with a combination of granisetron and dexamethasone in patients undergoing middle ear surgery

We have compared the efficacy of granisetron in combination with dexamethasone with each drug alone in the prevention of postoperative nausea and vomiting (PONV) after middle ear surgery. In a randomized, double-blind study, 120 patients (85 females) received granisetron 3 mg, dexamethasone 8 mg or granisetron 3 mg with dexamethasone 8 mg i.v. (n = 40 in each group), immediately before induction of anaesthesia. A standardized 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 recorded in 83%, 50% and 98% of patients who had received granisetron, dexamethasone and granisetron-dexamethasone, respectively. The corresponding incidences during the next 21 h after anaesthesia were 80%, 55% and 98% (P < 0.05; overall Fisher's exact probability test). In summary, prophylactic use of combined granisetron and dexamethasone was more effective than each antiemetic alone for the prevention of PONV after middle ear surgery.      

Analgesic and antiemetic effect of ketorolac vs. betamethasone or dexamethasone after ambulatory surgery

BACKGROUND: Glucocorticoids are known to provide slower onset and more prolonged duration of analgesic effect than ketorolac. In the present study, we wanted to evaluate the effect over time from a single dose of either intravenous (i.v.) dexamethasone or an intramuscular (i.m.) depot formulation of betamethasone compared with i.v. ketorolac. MATERIALS AND METHODS: One hundred and seventy-nine patients admitted for mixed ambulatory surgery were included in the study. After induction of general i.v. anaesthesia, the patients were randomized to receive double-blindly either dexamethasone 4 mg i.v. (Group D) or betamethasone depot formulation 12 mg i.m. (Group B) or ketorolac 30 mg i.v. (Group K). Fentanyl was used for rescue analgesic medication in the post-operative care unit (PACU) and codeine with paracetamol after discharge, for a study period of 3 days. RESULTS: There was significantly less post-operative pain in the ketorolac group during the stay in the unit (88% with minor or less pain in Group K vs. 74% and 67% in Groups D and B, respectively, P < 0.05), significantly less need for rescue medication (P < 0.05) and significantly less nausea or vomiting (12% in Group K vs. 30% in the other groups pooled, P < 0.05). The ketorolac patients were significantly faster for ready discharge, median 165 min vs. 192 min and 203 min in Groups D and B, respectively (P < 0.01). There were no differences between the groups in perceived pain, nausea, vomiting or rescue analgesic consumption in the 4- to 72-h period. CONCLUSION: Dexamethasone 4 mg or bethamethasone 12 mg did not provide prolonged post-operative analgesic effect compared with ketorolac 30 mg, which was superior for analgesia and antiemesis in the PACU.     

RETRACTED ARTICLE: Prophylactic antiemetic therapy with droperidol in patients undergoing laparoscopic cholecystectomy

Purpose. The incidence of postoperative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC) is relatively high when no prophylactic antiemetic is given. We have studied the efficacy of a commonly used and well-established antiemetic, droperidol, for the prevention of PONV in patients undergoing LC. Methods. In a randomized, double-blind, placebo-controlled study, 60 patients received placebo (saline) or droperidol 50 μg·kg⁻¹ (maximum dose, 2.5 mg) intravenously immediately before the induction of anesthesia (n = 30 of each). A standard general anesthetic technique was employed throughout. Results. A complete response, defined as no PONV and no need for another rescue antiemetic medication during the first 24 h after anesthesia, was 57% and 83% in patients who had received placebo and droperidol 50 μg·kg⁻¹, respectively (P < 0.05). No clinically serious adverse events were observed in any of the groups. Conclusion. Prophylactic antiemetic therapy with droperidol 50 μg·kg⁻¹ (maximum dose, 2.5 mg) is highly effective for preventing PONV after LC. Received for publication on August 3, 1998; accepted on February 23, 1999     

异丙酚对腹腔镜胆囊切除病人术后恶心呕吐的防治作用

目的 探讨异丙酚的镇吐作用及可能的作用机制。方法 60例ASAⅠ－Ⅱ级行择期腹腔镜胆囊切除术患者,随机分为三组;对照组（C组）行常规气管插管吸入全麻,恩丹西酮组（O组）入室后静脉注射恩丹西酮4mg,其他处理C组,异丙酚组（P组）诱导插管同C组,麻醉维持用异丙酚微泵静滴。分别测定入室（基础值）、气管插管后、术毕、术后6h血浆胃动素的水平,并观察术后恶心呕吐程度及发生率。结果 C组20例中9例发生Ⅱ－Ⅲ级恶心、呕吐,发生率为56．7％,O组为4例,P组为3例,发生率分别为20％、13．3％。围术期胃动素水平：C组术毕明显高于基础值（P＞0．01）,术后P明显低于C组及O组。结论 异丙酚静脉麻醉能降低腹腔镜胆囊切除术后恶心呕吐发生率,可能与抑制血浆胃动素合成及分泌有关。     

RETRACTED ARTICLE: Prophylactic antiemetic therapy with granisetron-droperidol combination in patients undergoing laparoscopic cholecystectomy

Purpose

A relatively high incidence of postoperative nausea and vomiting (PONV) occurs in patients undergoing laparoscopic cholecystectomy. This study was undertaken to compare the efficacy of granisetron-droperidol combination with each drug alone for the prevention of PONV after laparoscopic cholecystectomy.

Methods

In a randomized, double-blind manner, 150 female inpatients received 3 mg granisetron (Group G), 1.25 mg droperidol (Group D) or 3 mg granisetron plus 1.25 mg droperidol (Group GD) (n = 50 for each)iv immediately before the induction of anaesthesia. The same standard general anaesthetic technique, which consisted of isoflurane and nitrous oxide in oxygen, was used. Nausea, vomiting and safety assessments were performed continuously during the first 24 hr after anaesthesia.

Results

Complete response, defined as no PONV and no administration of rescue antiemetic medication, was 86% in Group G, 64% in Group D and 98% in Group GD (P = 0.03 vs Group G,P = 0.001 vs Group D). No clinically adverse events were observed in any group.

Conclusion

Granisetron-droperidol combination is more effective than each antiemetic alone in the prevention of PONV after laparoscopic cholecystectomy.     

Prophylactic antiemetic effect of midazolam after middle ear surgery.

OBJECTIVE: To investigate the prophylactic antiemetic effect of midazolam after middle ear surgery. STUDY DESIGN: A prospective, randomized, double-blind, placebo-controlled study. SUBJECTS AND METHODS: Ninety women patients undergoing middle ear surgery with general anesthesia received intravenously either midazolam 0.075 mg/kg or normal saline (n = 45 each) after induction of anesthesia. The incidence and severity of postoperative nausea and vomiting, rescue antiemetics, pain intensity, and side effects such as headache, dizziness, and drowsiness were assessed during the first 24 hours after anesthesia. RESULTS: Midazolam groups showed total incidence and severity of nausea and vomiting. Patients who required rescue antiemetics were significantly lower than in saline group (P < 0.05), but there were no significant differences in pain intensity and side effects such as headache, dizziness, and drowsiness between groups. CONCLUSIONS: Midazolam 0.075 mg/kg is effective for reducing nausea and vomiting after middle ear surgery.     

Antiemetic effect of naloxone in combination with dexamethasone and droperidol in patients undergoing laparoscopic gynecological surgery

Purpose

We examined the effects of dexamethasone, droperidol, naloxone, and a combination of these three agents on postoperative nausea and vomiting (PONV) in female patients.

Methods

In this randomized, controlled study, 120 female patients with ASA PS I or II undergoing laparoscopic gynecological surgery were randomly allocated into four groups. Patients received dexamethasone 8 mg (Dx group) or droperidol 1 mg (Dr group) before induction of general anesthesia. Anesthesia was induced and maintained with propofol and remifentanil. Postoperative analgesia was provided by intravenous patient-controlled analgesia using a disposable infusion pump filled with fentanyl 20 μg/kg alone (Dx group), fentanyl 20 μg/kg with droperidol 2 mg (Dr group), fentanyl 20 μg/kg with naloxone 0.1 mg (Nx group), or fentanyl 20 μg/kg with droperidol 2 mg and naloxone 0.1 mg (Cm group) in a total volume of 80 ml, with a constant infusion rate of 4 ml/h and a bolus dose 2 ml with a 30-min lockout time.

Results

The number of patients who developed PONV and required a rescue antiemetic was significantly less in the Cm group than in the Nx group (p < 0.001 for all). The incidence of PONV was 43, 43, 70, and 17 % in the Dx, Dr, Nx, and Cm groups, respectively.

Conclusion

A combination of naloxone, droperidol, and dexamethasone was effective for preventing PONV in patients receiving fentanyl for postoperative analgesia after laparoscopic gynecological surgery, although further investigations are required to examine the effect of adding naloxone to other antiemetics.     

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.     

Sevoflurane with or without antiemetic prophylaxis of dexamethasone in spontaneously breathing patients undergoing outpatient anorectal surgery

Study ObjectiveTo evaluate the prophylactic use of dexamethasone with sevoflurane in outpatient anorectal surgery.DesignRandomized, controlled study.SettingOperating room and Postanesthesia Care Unit of a general hospital.Patients60 adult, ASA physical status I and II outpatients undergoing anorectal surgery.InterventionsPatients were randomized to receive either dexamethasone 5 mg intravenously (IV; Group D; n = 30) or an equal volume of saline (Group S; n = 30) before anesthesia induction. Anesthesia was induced with propofol 2.5 mg.kg^?1, fentanyl two μg.kg^?1, and 2% lidocaine one mg.kg^?1 followed by placement of a Laryngeal Mask Airway.MeasurementsFrequency of postoperative nausea and vomiting (PONV), visual analog scale (VAS) pain scores, and patient satisfaction were recorded.Main ResultsFrequency of PONV and VAS pain scores were significantly lower in Group D than Group S (P < 0.05). The time required for “home readiness” was significantly shorter in Group D than Group S (P < 0.05).ConclusionsThe prophylactic administration of 5 mg dexamethasone IV can reduce the frequency of PONV, lower VAS pain scores, facilitate recovery to home readiness, and improve satisfaction in outpatients undergoing anorectal surgery.     

Low-dose dexamethasone effectively prevents postoperative nausea and vomiting after ambulatory laparoscopic surgery

PURPOSE: To evaluate the prophylactic effect of low-dose dexamethasone (5 mg) on postoperative nausea and vomiting (PONV) in women undergoing ambulatory laparoscopic surgery. Metoclopramide and saline served as controls. METHODS: One hundred twenty women (n=40 in each of the three groups) undergoing ambulatory laparoscopic tubal ligation under general anesthesia were enrolled in this randomized, double-blinded, placebo-controlled study. After tracheal intubation, group I received i.v. dexamethasone 5 mg, whereas groups II and III received i.v. metoclopramide 10 mg and saline, respectively. RESULTS: Patients in group I reported a lower incidence of PONV and requested less rescue antiemetics than those in group III during the first four postoperative hours (P <0.01). Patients in group I reported a lower incidence of PONV than those in groups II (P <0.05) and III (P <0.01) during the 24-hr postoperative period. Groups II and III did not differ from each other in the incidence of PONV and the proportion of patients who requested rescue antiemetics. CONCLUSION: Prophylactic iv dexamethasone 5 mg significantly reduces the incidence of PONV in women undergoing ambulatory laparoscopic tubal ligation. At this dose, dexamethasone is more effective than metoclopramide 10 mg or placebo.     

Haloperidol or droperidol with dexamethasone for antiemetic prophylaxis in laparoscopic cholecystectomy

OBJECTIVES: To compare haloperidol to droperidol, both with dexamethasone, for antiemetic prophylaxis in elective laparoscopic cholecystectomy. MATERIAL AND METHODS: Prospective, randomized double-blind trial enrolling 75 ASA 1-2 patients who received anesthesia with propofol and remifentanil. After induction, 8 mg of intravenous dexamethasone was administered. After surgery, depending on group assignment, patients received 10 microg x kg(-1) of intravenous haloperidol (n = 25), 10 microg x kg(-1) of droperidol (n = 25), or physiologic saline solution (n = 25). Outcomes recorded were episodes of nausea or vomiting in the postoperative period (first 6 hours and/or 6-24 hours), requirement for antiemetic agents, morphine consumption, pain assessed on a visual analog scale, level of sedation, and adverse effects. RESULTS: Five patients in the haloperidol group, 6 in the droperidol group, and 13 in the control group experienced an episode of nausea or vomiting in the 24-hour postoperative period (P < .05 between the active treatment groups and the control group). One patient in the haloperidol group, 6 in the droperidol group, and 8 in the control group reported nausea in the first 6 hours (P < .05). Three patients in the haloperidol group, 1 in the droperidol group, and 8 in the control group reported nausea in the later postoperative period (6-24 hours) (P < .05, droperidol vs control). Three patients in the haloperidol group, 1 in the droperidol group, and 7 in the control group experienced late vomiting (P < .05, droperidol vs control). CONCLUSIONS: Either haloperidol or droperidol in combination with dexamethasone is more effective than dexamethasone alone for antiemetic prophylaxis after laparoscopic cholecystectomy.     

Prospective randomized, double-blind comparative study of dexamethasone, ondansetron, and ondansetron plus dexamethasone as prophylactic antiemetic therapy in patients undergoing day-case gynaecological surgery

Dexamethasone alone and in combination with selective 5-hydroxytryptaminereceptor antagonists is of benefit in the prophylaxis of post-operativenausea and vomiting. In this study, the effectiveness of sucha combination in comparison to either drug alone is investigatedin day case gynaecological surgery. A total of 177 patientswere randomized to three treatment groups: dexamethasone 8 mg,ondansetron 4 mg, and dexamethasone 8 mg plus ondansetron 4mg. The only significant difference between groups was seenin the first 3 h when failure of prophylaxis was more frequentin patients who had received dexamethasone alone (P=0.0085;Fisher’s exact probability test). Confidence intervalanalysis indicates a modest treatment effect for the combinationand the decision whether to perform a larger study depends uponwhether such an effect is clinically relevant. Br J Anaesth 2001; 87: 588–92     

Day-case (ambulatory) laparoscopic surgery

Surgical Endoscopy -     

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.     

The use of oral granisetron versus intravenous ondansetron for antiemetic prophylaxis in patients undergoing laparoscopic surgery: the effect on emetic symptoms and quality of recovery

Based on comparative studies in patients receiving emetogenic chemotherapy, it has been suggested that granisetron would be more effective than ondansetron for the prevention of postdischarge nausea and vomiting (PDNV). However, there have been no direct comparisons of these two popular 5-HT3 antagonists with respect to PDNV and quality of recovery. We designed this randomized, double-blind study to compare the antiemetic efficacy of oral granisetron (1 mg) to a standard IV dose of ondansetron (4 mg) when administered for antiemetic prophylaxis as part of a multimodal regimen in a laparoscopic surgical population. A total of 220 patients undergoing laparoscopic surgery with a standardized general anesthetic technique were enrolled in this prospective study at two major medical centers. Patients were randomly assigned to one of two prophylactic treatment groups: the control (ondansetron) group received an oral placebo 1 h before surgery and ondansetron, 4 mg IV, at the end of the surgery, and the granisetron group received granisetron, 1 mg per os, 1 h before surgery, and normal saline, 2 mL IV, at the end of the surgery. The early recovery profiles, requirement for rescue antiemetics, incidence of PDNV, and the side effects were recorded over the 48 h study period. In addition, nausea scores were assessed using an 11-point verbal rating scale at specific intervals in the postoperative period. The quality of recovery and patient satisfaction scores were recorded at 48 h after surgery. The demographic characteristics were similar in the two prophylaxis treatment groups, as well as the recovery times to patient orientation, oral intake, and hospital discharge. The incidences of PDNV, requirements for rescue antiemetics, and quality of recovery did not differ between the two study groups. The antiemetic drug acquisition costs to achieve comparable patient satisfaction with ondansetron and granisetron were US 25.65 dollars and 47.05 dollars, respectively. Therefore, ondansetron (4 mg IV) was more cost-effective than granisetron (1 mg per os) for routine antiemetic prophylaxis as part of a multimodal regimen in patients undergoing either outpatient or inpatient laparoscopic surgery.