| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Placebo (group 1)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 62 Received treatment (n): 62 Analysed (n): 62 Age (mean ± SD, median (IQR), median (range)): 39 (18 to 60) Weight (mean ± SD, median (IQR), median (range)): 67 ± 11 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 77.42 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl for induction, 3.5 mg morphine postoperative Type of surgery: gynaecological or biliary surgical procedures by laparotomy or laparoscopy
Droperidol (group 2)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 60 Received treatment (n): 60 Analysed (n): 60 Age (mean ± SD, median (IQR), median (range)): 38 (18 to 60) Weight (mean ± SD, median (IQR), median (range)): 63 ± 10 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 81.67 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl for induction, 2.8 mg morphine postoperative Type of surgery: gynaecological or biliary surgical procedures by laparotomy or laparoscopy
Ondansetron (group 3)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 57 Received treatment (n): 57 Analysed (n): 57 Age (mean ± SD, median (IQR), median (range)): 38 (19 to 60) 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 %): 77.19 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl for induction, 3.2 mg morphine postoperative Type of surgery: gynaecological or biliary surgical procedures by laparotomy or laparoscopy
Droperidol + ondansetron (group 4)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 63 Received treatment (n): 63 Analysed (n): 63 Age (mean ± SD, median (IQR), median (range)): 40 (18 to 60) Weight (mean ± SD, median (IQR), median (range)): 66 ± 11 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 82.54 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl for induction, 3.1 mg morphine postoperative Type of surgery: gynaecological or biliary surgical procedures by laparotomy or laparoscopy
Included criteria: ASA I or II, 18 to 60 years of age, undergoing elective gynaecological or biliary surgical procedures by laparotomy or laparoscopy
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear |
| Interventions |
Intervention characteristics
Placebo (group 1)
Dose: saline Time point of administration: before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Droperidol (group 2)
Dose: 2.5 mg Time point of administration: before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Ondansetron (group 3)
Dose: 4 mg Time point of administration: before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Droperidol + ondansetron (group 4)
Dose: droperidol 2.5 mg, ondansetron 4 mg Time point of administration: before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 6 hours)
Nausea (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Chile
Setting: inpatient, NA
Author's name: G. Bugedo
Institution: Departamento de Anestesiologı ´a, Hospital Clı ´nico Pontificia Universidad Cato ´lica de Chile
Email: NA
Address: Departamento de Anestesiologı ´a, Hospital Clı ´nico Pontificia Universidad Cato ´lica de Chile, PO Box 114‐D, Santiago, Chile
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: NA |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Judgement comment: quote: "patients were allocated by random numbers" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "the anaesthetist and investigator were blinded to..." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: no statement |
| 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, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear |
