Study characteristics |
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
Participants |
Baseline characteristics Placebo
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): NA
Received treatment (n): NA
Analysed (n): 50
Age (mean ± SD, median (IQR), median (range)): 51 ± 19
Weight (mean ± SD, median (IQR), median (range)): 72 ± 17
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): 30/15/5/0
Gender (female in %): 56
Non‐smoker (%): NA
History of PONV/motion sickness (%): NA
Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 62
Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required
Type of surgery: cholecystectomy, parotid, proctologic surgery, thyroidectomy, mastectomy, varicosectomy
Droperidol
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): NA
Received treatment (n): NA
Analysed (n): 50
Age (mean ± SD, median (IQR), median (range)): 49 ± 16
Weight (mean ± SD, median (IQR), median (range)): 76.5 ± 16
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): 26/20/3/1
Gender (female in %): 50
Non‐smoker (%): NA
History of PONV/motion sickness (%): NA
Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 66
Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required
Type of surgery: cholecystectomy, parotid, proctologic surgery, thyroidectomy, mastectomy, varicosectomy
Ondansetron
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): NA
Received treatment (n): NA
Analysed (n): 45
Age (mean ± SD, median (IQR), median (range)): 52 ± 15
Weight (mean ± SD, median (IQR), median (range)): 75 ± 17
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): 27/16/2/0
Gender (female in %): 53.3
Non‐smoker (%): NA
History of PONV/motion sickness (%): NA
Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 61
Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required
Type of surgery: cholecystectomy, parotid surgery, proctologic surgery, thyroidectomy, mastectomy, varicosectomy
Included criteria: age over 18 years, elective surgery that "was considered emetogenic", ASA I to III 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 Placebo
Dose: 125 ml NaCl
Time point of administration: 30 minutes before anaesthesia
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
Droperidol
Dose: 1 mg
Time point of administration: 30 minutes before anaesthesia
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
Ondansetron
Dose: 4 mg
Time point of administration: 30 minutes before anaesthesia
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
|
Outcomes |
Vomiting (0 to 24 hours)
PONV (0 to 24 hours)
|
Identification |
Sponsorship source: NA Country: France Setting: inpatient, single‐centre Author's name: D.R. Badaoui Institution: Department of Anesthesia Resuscitation B, Chu Nord Email: NA Address: Départment d'Anesthésie‐Réanimation B, CHU Nord, place Victor‐Pauchet, 80054 Amiens Cedex 01 Duration of study: February to July 1997 Language: French (2 reviewers: MSS, AA) 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 |
Unclear risk |
Judgement comment: it is stated that 150 participants have been included and 145 CRFs were analysable. No reasons/further information for exclusion of the 5 participants, which apparently have been all in the ondansetron arm, are provided |
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 |