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

Laha 2013.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Palonosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 43.3 ± 14.25

  • Weight (mean ± SD, median (IQR), median (range)): 57.1 ± 9.61

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 10.20

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 90

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl intraoperative

  • Type of surgery: laparoscopic cholecystectomy


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 44.9 ± 13.36

  • Weight (mean ± SD, median (IQR), median (range)): 60.4 ± 9.99

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 24.49

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 79.2 ± 24.3

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl intraoperative

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: over 18 years age, either sex, undergoing elective laparoscopic cholecystectomy at a tertiary care hospital
Excluded criteria: pregnancy; body weight > 30% of ideal body weight; distinct spells of nausea, vomiting, or retching within 24 hours before surgery; use of corticosteroids, psychoactive drugs, or any other medication with known emetic or antiemetic effect within 24 hours before surgery; significant disease of major organs like liver, kidneys, heart, lungs, and bone marrow; known hypersensitivity to study medication; history of alcohol or substance abuse; participation in any other clinical trial within the last month
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Palonosetron
  • Dose: 75 μg

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

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg PO


Ondansetron
  • Dose: 4 mg

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

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg PO

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


Subjects with any AE (0 to 24 hours)
  • Outcome type: dichotomous outcome


Constipation (time point unknown)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: nil
Country: India
Setting: inpatient, single‐centre
Author's name: Avijit Hazra
Institution: NA
Email: ni.oc.oohay@snafwolb
Address: NA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: PONV
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "simple randomization was done in 1:1 ratio on the basis of a computer generated random number list"
Allocation concealment (selection bias) Low risk Quote: "generated random number list and allocation was concealed till the point of drug administration using serially numbered opaque sealed envelopes. The medication was administered..."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "single blind manner, taking care to ensure that the patient was not aware of the exact identity of the antiemetic drug"
Judgement comment: personnel was aware of the study drug
Blinding of outcome assessment (detection bias)
All outcomes High risk Judgement comment: personnel was aware of the study drug
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "the study was completed by all recruited subjects"
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): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear