| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, combination prophylaxis |
| Participants |
Baseline characteristics
Promethazine + ondansetron (females)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 26 Age (mean ± SD, median (IQR), median (range)): 48.3 ± 16.6 Weight (mean ± SD, median (IQR), median (range)): 68.3 ± 10.7 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 (%): 3.85/7.69 Type of general anaesthesia: inhalational anaesthesia (N2O) Duration of anaesthesia or surgery (in min; as mean or median): 102.6 Use of perioperative opioids (if yes, which?): 75 mg meperidine as premedication, 2 µg/kg fentanyl at induction Type of surgery: laparoscopic cholecystectomy
Promethazine + metoclopramide (females)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 27 Age (mean ± SD, median (IQR), median (range)): 41.3 ± 13.4 Weight (mean ± SD, median (IQR), median (range)): 69.1 ± 11.6 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 11.11/7.41 Type of general anaesthesia: inhalational anaesthesia (N2O) Duration of anaesthesia or surgery (in min; as mean or median): 90.9 Use of perioperative opioids (if yes, which?): 75 mg meperidine as premedication, 2 µg/kg fentanyl at induction Type of surgery: laparoscopic cholecystectomy
Promethazine + ondansetron (males)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 18 Age (mean ± SD, median (IQR), median (range)): 47.1 ± 12.7 Weight (mean ± SD, median (IQR), median (range)): 87.5 ± 18.0 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 0 Non‐smoker (%): NA History of PONV/motion sickness (%): 5.56/0 Type of general anaesthesia: inhalational anaesthesia (N2O) Duration of anaesthesia or surgery (in min; as mean or median): 103.3 Use of perioperative opioids (if yes, which?): 75 mg meperidine as premedication, 2 µg/kg fentanyl at induction Type of surgery: laparoscopic cholecystectomy
Promethazine + metoclopramide (males)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 14 Age (mean ± SD, median (IQR), median (range)): 43.5 ± 9.8 Weight (mean ± SD, median (IQR), median (range)): 84.3 ± 18.8 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 0 Non‐smoker (%): NA History of PONV/motion sickness (%): 7.14/7.14 Type of general anaesthesia: inhalational anaesthesia (N2O) Duration of anaesthesia or surgery (in min; as mean or median): 115.8 Use of perioperative opioids (if yes, which?): 75 mg meperidine as premedication, 2 µg/kg fentanyl at induction Type of surgery: laparoscopic cholecystectomy
Included criteria: ASA I and II, scheduled for laparoscopic cholecystectomy
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
| Interventions |
Intervention characteristics
Promethazine + ondansetron (females)
Dose: promethazine 25 mg, ondansetron 4 mg Time point of administration: promethazine 45 minutes before induction of anaesthesia, ondansetron after induction Route of administration: promethazine IM, ondansetron IV Rescue antiemetics (if yes, which?): NA
Promethazine + metoclopramide (females)
Dose: promethazine 25 mg, metoclopramide 10 mg Time point of administration: promethazine 45 minutes before induction of anaesthesia, metoclopramide after induction Route of administration: promethazine IM, metoclopramide IV Rescue antiemetics (if yes, which?): NA
Promethazine + ondansetron (males)
Dose: promethazine 25 mg, ondansetron 4 mg Time point of administration: promethazine 45 minutes before induction of anaesthesia, ondansetron after induction Route of administration: promethazine IM, ondansetron IV Rescue antiemetics (if yes, which?): NA
Promethazine + metoclopramide (males)
Dose: promethazine 25 mg, metoclopramide 10 mg Time point of administration: promethazine 45 minutes before induction of anaesthesia, metoclopramide after induction Route of administration: promethazine IM, metoclopramide IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Vomiting (0 to 24 hours)
|
| Identification |
Sponsorship source: NA
Country: Lebanon
Setting: inpatient, single‐centre
Author's name: Gattas Khoury
Institution: Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon
Email: NA
Address: Department of Surgery, American University of Beirut Medical Center, Box B‐37, P.O. Box 113‐6044, Beirut, Lebanon
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA |
| Notes |
Four groups pooled into 2 groups with same interventions for analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "a random number was used to assign prospectively each patient to receive after induction of anesthesia either ondansetron 4 mg (A), or metoclopramide 10 mg (B)" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "the staff caring for these patients were blinded to the study drug received" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "an independent blinded observer recorded emetic episodes"
Quote: "after two hours, patients were discharged to the floor, where they were followed up to 24 hours by another independent observer; the number of patients who vomited was recorded in each group"
Quote: "the staff caring for these patients were blinded to the study drug received" |
| 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 |
Quote: "there were no differences between study groups with respect to age, anaesthetic technique, duration of operation, diabetes, days since the last menstrual period in females, or history of previous postoperative nausea and vomiting as well as the need for postoperative analgesics (Table 1)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
