| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis, dose‐finding study |
| Participants |
Baseline characteristics
Placebo (group P)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 43.6 ± 4.6 Weight (mean ± SD, median (IQR), median (range)): 55.5 ± 9.6 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 100 History of PONV/motion sickness (%): 32 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 137.4 Use of perioperative opioids (if yes, which?): fentanyl via PCA Type of surgery: gynaecological surgery
Ramosetron (group R15)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 43.2 ± 9.1 Weight (mean ± SD, median (IQR), median (range)): 58.0 ± 8.3 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 100 History of PONV/motion sickness (%): 34 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 120.6 Use of perioperative opioids (if yes, which?): fentanyl via PCA Type of surgery: gynaecological surgery
Ramosetron (group R30)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 45.8 ± 11.7 Weight (mean ± SD, median (IQR), median (range)): 58.5 ± 8.6 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 100 History of PONV/motion sickness (%): 26 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 138.6 Use of perioperative opioids (if yes, which?): fentanyl via PCA Type of surgery: gynaecological surgery
Ramosetron (group R45)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 40.1 ± 10.6 Weight (mean ± SD, median (IQR), median (range)): 55.3 ± 4.5 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 100 History of PONV/motion sickness (%): 36 Type of general anaesthesia: inhalational anaesthesia (sevoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 127.2 Use of perioperative opioids (if yes, which?): fentanyl via PCA Type of surgery: gynaecological surgery
Included criteria: 25 to 60 years of age, ASA corresponding to body class I or II, undergoing general anaesthesia, non‐smoking status, had undergone surgery longer than 1 hour and less than 4 hours
Excluded criteria: gastrointestinal disorders such as gastritis and gastric ulcers, pregnant women, lactating women, had taken antiviral agent within 24 hours before the operation
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, non‐smoker): no; (perioperative opioids): unclear |
| Interventions |
Intervention characteristics
Placebo (group P)
Dose: saline Time point of administration: at completion of the operation Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 0.25 mg/kg
Ramosetron (group R15)
Dose: 0.15 mg Time point of administration: at completion of the operation Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 0.25 mg/kg
Ramosetron (group R30)
Dose: 0.3 mg Time point of administration: at completion of the operation Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 0.25 mg/kg
Ramosetron (group R45)
Dose: 0.45 mg Time point of administration: at completion of the operation Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 0.25 mg/kg
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Headache (0 to 48 hours)
Constipation (0 to 48 hours)
|
| Identification |
Sponsorship source: NA
Country: South Korea
Setting: inpatient, single‐centre
Author's name: Young‐Kyoo Choi
Institution: Department of Anesthesiology and Pain Medicine, College of Medicine, Kyung Hee University, Seoul, Korea
Email: cykyko@unitel.co.kr
Address: NA
Duration of study: NA
Language: Korean (Google Translator)
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: "was 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 |
Low risk |
Judgement comment: quote: "the drug was prepared according to the arm by an anesthesiologist who does not know what type of medication is being administered" (translated) |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Judgement comment: quote: "a designated anesthesiologist who does not know the grouping of patients" |
| 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, duration of anaesthesia, history of PONV/motion sickness, non‐smoker): no; (perioperative opioids): unclear |
