| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Ondansetron
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 15 Received treatment (n): NA Analysed (n): 15 Age (mean ± SD, median (IQR), median (range)): 42.8 ± 1.5 Weight (mean ± SD, median (IQR), median (range)): 72.4 ± 3.3 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): 101.3 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 15 Received treatment (n): NA Analysed (n): 15 Age (mean ± SD, median (IQR), median (range)): 44.8 ± 1.4 Weight (mean ± SD, median (IQR), median (range)): 73.5 ± 2.8 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): 105.6 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Ondansetron + droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 13 Received treatment (n): NA Analysed (n): 13 Age (mean ± SD, median (IQR), median (range)): 44.2 ± 1.8 Weight (mean ± SD, median (IQR), median (range)): 73.6 ± 3.34 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): 109.4 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 15 Received treatment (n): NA Analysed (n): 15 Age (mean ± SD, median (IQR), median (range)): 41.3 ± 0 Weight (mean ± SD, median (IQR), median (range)): 75.3 ± 0 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): 104.3 Use of perioperative opioids (if yes, which?): NA Type of surgery: major gynaecological surgery
Included criteria: ASA I or II, women undergoing major gynaecological surgery
Excluded criteria: NA
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
Dose: 8 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Droperidol
Dose: 5 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Ondansetron + droperidol
Dose: ondansetron 4 mg, droperidol 5 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Placebo
Dose: saline Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Vomiting (0 to 24 hours)
Vomiting (6 to 24 hours)
Nausea (0 to 24 hours)
|
| Identification |
Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Fuat Güldogus
Institution: NA
Email: NA
Address: NA
Duration of study: NA
Language: Turkish (translated by Emine Yesil)
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 |
Judgement comment: quote: "randomized" (translated). No further information 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 |
Judgement comment: quote: "double‐blind" (translated). Insufficient information on blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: quote: "double‐blind" (translated). Insufficient information on blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Judgement comment: no statement on missing outcome data; no missing outcome data assumed |
| 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, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
