| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis, dose‐finding study |
| Participants |
Baseline characteristics
Placebo (study 1/2)
Assessed for eligibility (n): NA Enrolled (n): NA Randomized (n): NA Received treatment (n): NA Analysed (n): 282; 139 (study 1), 143 (study 2) Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (isoflurane, N₂O, fentanyl or alfentanil) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl, alfentanil Type of surgery: gynaecological, orthopaedic, peripheral, ENT/oral
Ondansetron (1 mg group ‐ study 1/2)
Assessed for eligibility (n): NA Enrolled (n): NA Randomized (n): NA Received treatment (n): NA Analysed (n): 264; 133 (study 1), 131 (study 2) Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (isoflurane, N₂O, fentanyl or alfentanil) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl, alfentanil Type of surgery: gynaecological, orthopaedic, peripheral, ENT/oral
Ondansetron (4 mg group ‐ study 1/2)
Assessed for eligibility (n): NA Enrolled (n): NA Randomized (n): NA Received treatment (n): NA Analysed (n): 272; 136 (study 1), 136 (study 2) Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (isoflurane, N₂O, fentanyl or alfentanil) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl, alfentanil Type of surgery: gynaecological, orthopaedic, peripheral, ENT/oral
Ondansetron (8 mg group ‐ study 1/2)
Assessed for eligibility (n): NA Enrolled (n): NA Randomized (n): NA Received treatment (n): NA Analysed (n): 265; 136 (study 1), 129 (study 2) Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (isoflurane, N₂O, fentanyl or alfentanil) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl, alfentanil Type of surgery: gynaecological, orthopaedic, peripheral, ENT/oral
Included criteria: in study 1, ASA grade I or II, female, 18 to 70 years of age, scheduled to undergo gynaecological laparoscopy on a day‐case basis; in study 2, female, 18 to 70 years of age, scheduled to undergo day‐case surgery
Excluded criteria: had vomited or received antiemetics within 24 hours of surgery, pregnant or breastfeeding (studies 1 and 2), scheduled to undergo liver biopsy, required continuous gastric suction intraoperatively, > 100% over ideal body weight
Pretreatment: baseline characteristics (age, ASA, weight): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids, duration of anaesthesia): unclear |
| Interventions |
Intervention characteristics
Placebo (study 1/2)
Dose: 20 mL normal saline Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): "rescue antiemetics were allowed upon request or after physician determination"
Ondansetron (1 mg group ‐ study 1/2)
Dose: 1 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): "rescue antiemetics were allowed upon request or after physician determination"
Ondansetron (4 mg group ‐ study 1/2)
Dose: 4 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): "rescue antiemetics were allowed upon request or after physician determination"
Ondansetron (8 mg group ‐ study 1/2)
Dose: 8 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): "rescue antiemetics were allowed upon request or after physician determination"
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Headache (0 to 24 hours)
Sedation/drowsiness (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: USA
Setting: outpatient, NA
Author's name: M.H. Pearman
Institution: Department of Anesthesia, Baptist Medical Center
Email: NA
Address: Department of Anesthesia, Baptist Medical Center, 1330 Taylor Street, Columbia, South Carolina 29220, USA
Duration of study: NA
Language: English
Study's primary outcome: number of emetic episodes
Trial registry number: NA |
| Notes |
Three studies with 4 groups each. Only 2 out of 3 studies relevant
"Study 1" and "study 2" combined. "Study 3" excluded (patients ≥ 12 years of age) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Judgement comment: no information on sequence generation provided |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no information on allocation concealment provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Judgement comment: no information on blinding of participants and study personnel provided |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "vital signs, emetic episodes, nausea scores and adverse events were assessed by a blinded observer during this time"
Judgement comment: no information on blinding provided |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Judgement comment: in study 1 and study 2, about 9% of enrolled participants were not analysed. No information provided on 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 |
Quote: "in all three studies, there were no significant differences between treatment groups with regard to age, weight, height, number of days since last menstrual cycle..."
Judgement comment: baseline characteristics (age, ASA, weight): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids, duration of anaesthesia): unclear |
