| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis |
| Participants |
Baseline characteristics
Placebo (tramadol group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 45.0 ± 19.4 Weight (mean ± SD, median (IQR), median (range)): 74.0 ± 14.7 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 12/18/0/0 Gender (female in %): 68 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 142.4 Use of perioperative opioids (if yes, which?): tramadol 467.2 mg via PCA Type of surgery: lower extremity surgery
Ondansetron (tramadol group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 45.2 ± 19.2 Weight (mean ± SD, median (IQR), median (range)): 68.7 ± 13.9 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 12/18/0/0 Gender (female in %): 64 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 165.4 Use of perioperative opioids (if yes, which?): tramadol 646.6 mg via PCA Type of surgery: lower extremity surgery
Placebo (morphine group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 43.9 ± 14.9 Weight (mean ± SD, median (IQR), median (range)): 71.0 ± 11.3 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 10/20/0/0 Gender (female in %): 72 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 160.0 Use of perioperative opioids (if yes, which?): morphine 34.9 mg via PCA Type of surgery: lower extremity surgery
Ondansetron (morphine group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 44.9 ± 18.6 Weight (mean ± SD, median (IQR), median (range)): 68.5 ± 14.0 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 13/17/0/0 Gender (female in %): 50 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 160.4 Use of perioperative opioids (if yes, which?): morphine 35.4 mg via PCA Type of surgery: lower extremity surgery
Included criteria: ASA I or II, elective lower extremity surgery
Excluded criteria: severe CHD; renal or liver disease; motion sickness; history of PONV; over 18 years of age; lack of understanding in using PCA pump; allergy to morphine, ondansetron, or tramadol
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, history of PONV/motion sickness, duration of anaesthesia): no; (non‐smoker): unclear; (perioperative opioids): yes |
| Interventions |
Intervention characteristics
Placebo (tramadol group)
Dose: saline Time point of administration: at induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Ondansetron (tramadol group)
Dose: 0.1 mg/kg Time point of administration: at induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Placebo (morphine group)
Dose: saline Time point of administration: at induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Ondansetron (morphine group)
Dose: 4 mg Time point of administration: at induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Yasemin Günes
Institution: Cukurova University Faculty Of Medicine Department Of Anesthesiology, Adana, Turkey
Email: ygunes8cu.edu.tr
Address: Cukurova University Faculty of Medicine, Department of Anesthesiology, 01330, Adana, Turkey
Duration of study: NA
Language: Turkish (translated by Emine Yesil)
Study's primary outcome: NA
Trial registry number: NA |
| Notes |
Four groups (2 × tramadol, 2 × morphine). Same interventions (placebo, ondansetron) pooled for analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Judgement comment: quote: "randomly divided"
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: insufficient information on blinding ("double‐blind") |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Judgement comment: quote (translated): "outcome assessor was a blinded nurse" |
| 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 |
High risk |
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, history of PONV/motion sickness, duration of anaesthesia): no; (non‐smoker): unclear; (perioperative opioids): yes |
