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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Semira 2013.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 42.8 ± 8.2

  • Weight (mean ± SD, median (IQR), median (range)): 60.4 ± 7.1

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 24/6/0/0

  • Gender (female in %): 70

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

  • Type of general anaesthesia: inhalational anaesthesia (N₂O/isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 75.2

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: laparoscopic cholecystectomy


Dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 43.9 ± 10.4

  • Weight (mean ± SD, median (IQR), median (range)): 57.9 ± 8.0

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 23/7/0/0

  • Gender (female in %): 77

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

  • Type of general anaesthesia: inhalational anaesthesia (N₂O/isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 75.5

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: laparoscopic cholecystectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 39.6 ± 8.6

  • Weight (mean ± SD, median (IQR), median (range)): 60.3 ± 8.6

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 24/6/0/0

  • Gender (female in %): 63

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

  • Type of general anaesthesia: inhalational anaesthesia (N₂O/isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 79.4

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: USG diagnosed cholelithiasis scheduled for laparoscopic cholecystectomy under general anaesthesia, both sexes, ASA I and II
Excluded criteria: patients with 18 or above 60 years of age; unable to cooperate or epileptic; impaired kidney or liver function; history of hypersensitivity to any drug; history of peptic ulcer disease; taking psychotropic drugs, calcium channel blockers, or antidepressants; for whom laparoscopic cholecystectomy was converted into open cholecystectomy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: 10 to 15 minutes before surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): granisetron 1 mg IV


Dexamethasone
  • Dose: 8 mg

  • Time point of administration: 10 to 15 minutes before surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): granisetron 1 mg IV


Placebo
  • Dose: 2 mL saline

  • Time point of administration: 10 to 15 minutes before surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): granisetron 1 mg IV

Outcomes PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: India
Setting: inpatient, single‐centre
Author's name: Semira
Institution: SKIMS Medical College, Bemina Kashmir
Email: NA
Address: Department of Pharmacology, SKIMS medical college, Bemina Kashmir, India 190001
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes Three out of 4 groups relevant (gabapentin)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the table of random numbers..."
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: no statement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
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): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear