| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis |
| Participants |
Baseline characteristics
Ondansetron (group A)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 48.5 ± 19 Weight (mean ± SD, median (IQR), median (range)): 55.4 ± 17 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane) Duration of anaesthesia or surgery (in min; as mean or median): 174 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Droperidol (group B)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 50.5 ± 17 Weight (mean ± SD, median (IQR), median (range)): 56.4 ± 15 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane) Duration of anaesthesia or surgery (in min; as mean or median): 160 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Metoclopramide (group C)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 24 Age (mean ± SD, median (IQR), median (range)): 49.7 ± 14 Weight (mean ± SD, median (IQR), median (range)): 58.2 ± 13 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane) Duration of anaesthesia or surgery (in min; as mean or median): 170 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Placebo (group D)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 24 Age (mean ± SD, median (IQR), median (range)): 51.2 ± 13 Weight (mean ± SD, median (IQR), median (range)): 54.7 ± 17 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane) Duration of anaesthesia or surgery (in min; as mean or median): 168 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Included criteria: women undergoing major gynaecological surgery, ASA I or II, 16 to 70 years of age
Excluded criteria: taking drugs with antiemetic effects
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
| Interventions |
Intervention characteristics
Ondansetron (group A)
Dose: 4 mg Time point of administration: 10 minutes before the neuromuscular blockade was antagonized at the end of the procedure Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Droperidol (group B)
Dose: 2.5 mg Time point of administration: 10 minutes before the neuromuscular blockade was antagonized at the end of the procedure Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Metoclopramide (group C)
Dose: 10 mg Time point of administration: 10 minutes before the neuromuscular blockade was antagonized at the end of the procedure Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Placebo (group D)
Dose: saline Time point of administration: 10 minutes before the neuromuscular blockade was antagonized at the end of the procedure Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
|
| Outcomes |
Vomiting (0 to 6 hours)
Extrapyramidal symptoms (0 to 6 hours)
Sedation/drowsiness (0 to 6 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Malaysia
Setting: inpatient, single‐centre
Author's name: S. Sharma
Institution: Department of Anaesthesia and Critical Care Medicine School of Medical Studies University Science Malaysia
Email: ssharma@pc.jaring.my
Address: Department of Anaesthesia and Critical Care Medicine, School of Medical Studies, University Science Malaysia, Kubang Kerian, Kelantan, Malaysia
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "100 ASA physical status I‐Il undergoing major gynaecological surgery were randomized to receive intravenously (IV), one of the four test drugs 10 minutes before the end of anaesthesia"
Judgement comment: no details on sequence generation provided |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "double blind"
Judgement comment: insufficient information on blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "the observer was blinded to the study drug" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "one hundred patients were involved in the study initially; one patient each in the metoclopramide group and placebo group were excluded, because they had to be given opioid analgesic as the pain could not be controlled with keterolac" |
| Selective reporting (reporting bias) |
Unclear risk |
Judgement comment: no reference to a study protocol or trial registry number reported |
| Other bias |
Unclear risk |
Quote: "there was no statistically significant difference between the groups with regard to patients’ age and weight (Table I). The type of surgery performed, and the number of patients in each group who underwent abdominal or vaginal procedures was comparable"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
