| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis |
| Participants |
Baseline characteristics
Droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 40 ± 13 Weight (mean ± SD, median (IQR), median (range)): 61 ± 10 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 (%): 0 Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction, pethidine 1.5 mg/kg IM, if VAS > 5 for postoperative pain Type of surgery: laparoscopic cholecystectomy
Metoclopramide
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 41 ± 14 Weight (mean ± SD, median (IQR), median (range)): 61 ± 10 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 (%): 0 Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction, pethidine 1.5 mg/kg IM, if VAS > 5 for postoperative pain Type of surgery: laparoscopic cholecystectomy
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 42 ± 13 Weight (mean ± SD, median (IQR), median (range)): 64 ± 10 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 (%): 0 Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction, pethidine 1.5 mg/kg IM, if VAS > 5 for postoperative pain Type of surgery: laparoscopic cholecystectomy
Included criteria: women 20 to 60 years of age, ASA I or II
Excluded criteria: gastrointestinal disease, history of motion sickness and/or previous PONV, pregnancy or menstruation, had taken antiemetics within 24 hours before operation
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, history of PONV/motion sickness): no; (duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
| Interventions |
Intervention characteristics
Droperidol
Dose: 20 µg/kg Time point of administration: NA Route of administration: IV Rescue antiemetics (if yes, which?): granisetron 40 µg/kg
Metoclopramide
Dose: 0.2 mg/kg Time point of administration: NA Route of administration: IV Rescue antiemetics (if yes, which?): granisetron 40 µg/kg
Placebo
Dose: saline Time point of administration: NA Route of administration: IV Rescue antiemetics (if yes, which?): granisetron 40 µg/kg
|
| Outcomes |
Vomiting (0 to 24 hours)
PONV (0 to 24 hours)
Complete response (no PONV) in 24 hours
Headache (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: India
Setting: inpatient, single‐centre
Author's name: A. Rudra
Institution: Calcutta National Medical College, Kolkata
Email: NA
Address: NA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: complete control (no emesis, no rescue) in 24 hours |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "after extubation, based on the randomization table, patients were allocated in equal numbers into 3 groups" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "double blind manner"
Judgement comment: insufficient information on blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "patients and investigators who collected postoperative data were blinded to the study drug administered" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Judgement comment: no missing outcome data |
| Selective reporting (reporting bias) |
Unclear risk |
Judgement comment: no reference to a study protocol or trial registry number reported |
| Other bias |
Unclear risk |
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, history of PONV/motion sickness): no; (duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
