| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis |
| Participants |
Baseline characteristics
Placebo (group I)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (%): NA Type of general anaesthesia: combined anaesthesia (N₂O, propofol) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl Type of surgery: diagnostic or therapeutic gynaecological laparoscopic surgery
Metoclopramide (group II)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): NA Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (%): NA Type of general anaesthesia: combined anaesthesia (N₂O, propofol) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl Type of surgery: diagnostic or therapeutic gynaecological laparoscopic surgery
Ondansetron (group III)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): NA Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (%): NA Type of general anaesthesia: combined anaesthesia (N₂O, propofol) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl Type of surgery: diagnostic or therapeutic gynaecological laparoscopic surgery
Granisetron (group IV)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): NA Age (mean ± SD, median (IQR), median (range)): NA Weight (mean ± SD, median (IQR), median (range)): NA 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 (%): NA Type of general anaesthesia: combined anaesthesia (N₂O, propofol) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl Type of surgery: diagnostic or therapeutic gynaecological laparoscopic surgery
Included criteria: female patients, ASA grade I and II, 18 to 40 years of age, scheduled to undergo diagnostic or therapeutic gynaecological laparoscopic surgery
Excluded criteria: NA
Pretreatment: baseline characteristics (age, BMI, ASA ‐> no data provided): no. Potential effect modifiers (gender, duration of anaesthesia ‐> no data provided): no; (non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear |
| Interventions |
Intervention characteristics
Placebo (group I)
Dose: 0.9% saline Time point of administration: 10 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 16.67% (ondansetron 4 mg, dexamethasone 8 mg)
Metoclopramide (group II)
Dose: 10 mg Time point of administration: 10 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 13.33% (ondansetron 4 mg, dexamethasone 8 mg)
Ondansetron (group III)
Dose: 4 mg Time point of administration: 10 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 6.67% (ondansetron 4 mg, dexamethasone 8 mg)
Granisetron (group IV)
Dose: 3 mg Time point of administration: 10 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 3.33% (ondansetron 4 mg, dexamethasone 8 mg)
|
| Outcomes |
Sedation/drowsiness (0 hours to discharge)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: India
Setting: outpatient, single‐centre
Author's name: Nidhi Bhatia
Institution: Dept. of Anaesthesiology, Govt. Medical College Hospital
Email: bhatia.nidhi@yahoo.co.in
Address: 32B, Sector 32, Chandigarh, 160030, India
Duration of study: NA
Language: English
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 |
Quote: "were randomly divided into four groups of 30 patients"
Judgement comment: no 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 design") |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: insufficient information on blinding ("double‐blind design") |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Judgement comment: no missing outcome data (no statement, but data in tables (%) support the assumption of no missing 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: "patients in all the groups were statistically comparable as regards to age, body mass index (BMI) and duration of anaesthesia (DOA)"
Judgement comment: baseline characteristics (age, BMI, ASA ‐> no data provided): no. Potential effect modifiers (gender, duration of anaesthesia ‐> no data provided): no; (non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear |
