| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, combination prophylaxis |
| Participants |
Baseline characteristics
Placebo (group P)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 40 Received treatment (n): 40 Analysed (n): 40 Age (mean ± SD, median (IQR), median (range)): 35.94 ± 10.12 Weight (mean ± SD, median (IQR), median (range)): 55.18 ± 7.52 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 80 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 108.10 Use of perioperative opioids (if yes, which?): fentanyl 3 µg/kg before induction and 1 µg/kg to 2 µg/kg during anaesthesia Type of surgery: laparoscopic abdominal surgery
Granisetron + droperidol (group GDr)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 40 Received treatment (n): 40 Analysed (n): 40 Age (mean ± SD, median (IQR), median (range)): 36.50 ± 9.4 Weight (mean ± SD, median (IQR), median (range)): 56.32 ± 9.4 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 75 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 106.25 ± 10.68 Use of perioperative opioids (if yes, which?): fentanyl 3 µg/kg before induction and 1 µg/kg to 2 µg/kg during anaesthesia Type of surgery: laparoscopic abdominal surgery
Granisetron + dexamethasone (group GDx)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 40 Received treatment (n): 40 Analysed (n): 40 Age (mean ± SD, median (IQR), median (range)): 38.48 ± 10.12 Weight (mean ± SD, median (IQR), median (range)): 54.42 ± 10.25 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 77.5 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 108.90 ± 9.18 Use of perioperative opioids (if yes, which?): fentanyl 3 µg/kg before induction and 1 µg/kg to 2 µg/kg during anaesthesia Type of surgery: laparoscopic abdominal surgery
Dexamethasone + droperidol (group DxDr)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 40 Received treatment (n): 40 Analysed (n): 40 Age (mean ± SD, median (IQR), median (range)): 28.9 ± 10.22 Weight (mean ± SD, median (IQR), median (range)): 55.34 ± 8.92 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 80 Non‐smoker (%): NA History of PONV/motion sickness (%): 0 Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 107.10 ± 8.12 Use of perioperative opioids (if yes, which?): fentanyl 3 µg/kg before induction and 1 µg/kg to 2 µg/kg during anaesthesia Type of surgery: laparoscopic abdominal surgery
Included criteria: either sex, ASA I or II, 20 to 60 years of age, scheduled for laparoscopic abdominal surgery
Excluded criteria: gastrointestinal disease; history of postoperative nausea and vomiting (PONV); history of motion sickness; had received opioids, antiemetics, steroids, or NSAIDs; had hypersensitivity to any of the 3 drugs
Pretreatment: baseline characteristics (weight, ASA): no; (age): yes. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
| Interventions |
Intervention characteristics
Placebo (group P)
Dose: 5 mL saline Time point of administration: just before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 40% (ondansetron 4 mg)
Granisetron + droperidol (group GDr)
Dose: granisetron 3 mg, droperidol 1.25 mg Time point of administration: just before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 0% (ondansetron 4 mg)
Granisetron + dexamethasone (group GDx)
Dose: granisetron 3 mg, dexamethasone 8 mg Time point of administration: just before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 0% (ondansetron 4 mg)
Dexamethasone + droperidol (group DxDr)
Dose: dexamethasone 8 mg, droperidol 1.25 mg Time point of administration: just before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 7.5% (ondansetron 4 mg)
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Extrapyramidal symptoms (0 to 24 hours)
Headache (0 to 24 hours)
Constipation (0 to 24 hours)
Sedation/drowsiness (0 to 24 hours)
|
| Identification |
Sponsorship source: NA
Country: India
Setting: NA
Author's name: M. Khan
Institution: Department of Anesthesiology, CSM Medical University
Email: NA
Address: NA
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) |
Low risk |
Quote: "orally on the night before surgery. Patients were randomly allocated to one of the four groups using a computer generated table of random numbers. Group P: Patients received 5ml" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "combination with droperidol 1.25 mg. The study medications were prepared by the technician in identical syringes and in equal volume to make the study double blind. Neither the patient nor the observer was aware of the medication received by the patient. A standard protocol for general anesthesia"
Judgement comment: anaesthetists were not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "neither the patient nor the observer was aware of the medication received by the patient" |
| 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 |
Quote: "the treatment groups were comparable with regards to patient demographics and types of operation. A complete response was observed"
Judgement comment: baseline characteristics (weight, ASA): no; (age): yes. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
