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

Shora 2007.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis and combination prophylaxis
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)): 33.27 ± 8.53

  • Weight (mean ± SD, median (IQR), median (range)): 52.90 ± 7.27

  • 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 (%): 0

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, halothane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 65.27

  • Use of perioperative opioids (if yes, which?): morphine for induction

  • Type of surgery: laparoscopic cholecystectomy


Ondansetron + dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 32.47 ± 10.18

  • Weight (mean ± SD, median (IQR), median (range)): 52.70 ± 7.47

  • 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 (%): 0

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, halothane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 66.67

  • Use of perioperative opioids (if yes, which?): morphine for induction

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: female, 18 to 55 years of age, ASA I or II, undergoing laparoscopic cholecystectomy under general anaesthesia
Excluded criteria: history of motion sickness, migraine, PONV during previous surgery, pregnant or lactating
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
Ondansetron
  • Dose: 4 mg

  • Time point of administration: 1 minute before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): ondansetron 0.1 mg/kg


Ondansetron + dexamethasone
  • Dose: ondansetron 4 mg, dexamethasone 4 mg

  • Time point of administration: 1 minute before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): ondansetron 0.1 mg/kg

Outcomes Vomiting (0 to 6 hours)
  • Outcome type: dichotomous outcome


Vomiting (12 to 18 hours)
  • Outcome type: dichotomous outcome


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


Complete response (no PONV) in 24 hours
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: India
Setting: inpatient, single‐centre
Author's name: Asaf Nazir Shora
Institution: Sher‐i‐Kashmir Institute of Medical Sciences
Email: NA
Address: Soura, Bemina, Srinagar, Jammu and Kashmir 190011
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) Unclear risk Quote: "patients were randomly allocated into two groups of 30 patients each"
Judgement comment: 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 Unclear risk Quote: "patients included in the study. In the preoperative holding area, patients were randomly allocated into two groups of 30 patients each and received study medications prepared by a single person in identical 5 ml syringe and all study medications were diluted up to 4 ml in 0.9 % saline in order to ensure blinding"
Judgement comment: it is unclear whether the person preparing the syringes was further involved in the study
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "after surgery patients were observed for a period of 24 hours by the same anaesthetist"
Judgement comment: insufficient information 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, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear