| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis, dose‐finding study |
| Participants |
Baseline characteristics
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 139 Age (mean ± SD, median (IQR), median (range)): 30.2 ± 0.5 Weight (mean ± SD, median (IQR), median (range)): 64.2 ± 1.0 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 (%): 32/NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, enflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 40.7 Use of perioperative opioids (if yes, which?): 57% of patients received fentanyl or alfentanil Type of surgery: ambulant gynaecological laparoscopy
Ondansetron (1 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 133 Age (mean ± SD, median (IQR), median (range)): 30.2 ± 0.5 Weight (mean ± SD, median (IQR), median (range)): 64.4 ± 1.1 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 (%): 32/NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, enflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 39.1 Use of perioperative opioids (if yes, which?): 54% of patients received fentanyl or alfentanil Type of surgery: ambulant gynaecological laparoscopy
Ondansetron (4 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 136 Age (mean ± SD, median (IQR), median (range)): 31.0 ± 0.5 Weight (mean ± SD, median (IQR), median (range)): 65.3 ± 1.1 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 (%): 32/NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, enflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 39.4 Use of perioperative opioids (if yes, which?): 61% of patients received fentanyl or alfentanil Type of surgery: ambulant gynaecological laparoscopy
Ondansetron (8 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 136 Age (mean ± SD, median (IQR), median (range)): 30.3 ± 0.5 Weight (mean ± SD, median (IQR), median (range)): 66.0 ± 1.1 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 (%): 34/NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, enflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 39.7 Use of perioperative opioids (if yes, which?): 55% of patients received fentanyl or alfentanil Type of surgery: ambulant gynaecological laparoscopy
Included criteria: non‐pregnant, ASA I to II, women between 18 and 70 years of age, scheduled for gynaecological laparoscopy
Excluded criteria: any prophylactic antiemetics preceding surgery, > 75% over ideal body weight, scheduled to have gastric suction during or after surgery, abnormalities in clinical laboratory tests of liver function, scheduled to undergo a liver biopsy during surgery, pregnancy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear |
| Interventions |
Intervention characteristics
Placebo
Dose: saline 0.9% Time point of administration: immediately before induction Route of administration: IV Rescue antiemetics (if yes, which?): yes (discretion of investigator)
Ondansetron (1 mg group)
Dose: 1 mg Time point of administration: immediately before induction Route of administration: IV Rescue antiemetics (if yes, which?): yes (discretion of investigator)
Ondansetron (4 mg group)
Dose: 4 mg Time point of administration: immediately before induction Route of administration: IV Rescue antiemetics (if yes, which?): yes (discretion of investigator)
Ondansetron (8 mg group)
Dose: 8 mg Time point of administration: immediately before induction Route of administration: IV Rescue antiemetics (if yes, which?): yes (discretion of investigator)
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Subjects with any AE (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, multi‐centre (8)
Author's name: Ray McKenzie
Institution: Department of Anesthesiology, Magee‐Women's Hospital, Pittsburgh, Pennsylvania, USA
Email: NA
Address: Department of Anesthesiology, Magee‐Women's Hospital, 300 Halket Street, Pittsburgh, Pennsylvania 15213‐3180, USA
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) |
Unclear risk |
Judgement comment: quote: "... patients were randomized...".
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: "placebo (8 ml) or the appropriate volume of ondansetron (2 mg/ml) was admixed with normal saline to a final volume of 20 ml [...] in a double‐blind fashion"
It is not clear from the description if blinding was adequate (identical appearance of syringes, sequentially numbered) |
| 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: quote: "a total of 580 patients were enrolled in this study. Table 1 lists those patients in each treatment group who were not included in the analysis of efficacy because of protocol violations [...]. A total of 36 patients in the study had protocol violations [...] [which] affect either the incidence of [PONV] or the effectiveness of ondansetron" |
| 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, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear |
