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

Gugale 2016.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Granisetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 39.26 ± 13.20

  • Weight (mean ± SD, median (IQR), median (range)): 62.86 ± 10.07

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 50

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: laparoscopic surgery (appendectomy or cholecystectomy)


Palonosetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 38.03 ± 12.00

  • Weight (mean ± SD, median (IQR), median (range)): 63.16 ± 10.50

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 57

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: laparoscopic surgery (appendectomy or cholecystectomy)


Included criteria: 60 patients (18 to 65 years of age), ASA I and II, undergoing elective laparoscopic surgeries, either appendectomy or cholecystectomy
Excluded criteria: gynaecological laparoscopic surgeries
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear
Interventions Intervention characteristics
Granisetron

  • Dose: 0.05 mg/kg

  • Time point of administration: 30 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 70% (ondansetron 0.08 mg/kg)


Palonosetron

  • Dose: 1.5 µg/kg

  • Time point of administration: 30 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 20% (ondansetron 0.08 mg/kg)
Outcomes Subjects with any AE (0 to 72 hours)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, overall, exact time point unknown)

  • Outcome type: general notes on side effects
Identification Sponsorship source: nil
Country: India
Setting: inpatient, single‐centre
Author's name: Pradnya Milind Bhalerao
Institution: Department of Anaesthesiology and Critical Care, B.J. Government Medical College and Sassoon General Hospital, Pune, Maharashtra, India
Email: dr.pradnyabhalerao@gmail.com
Address: D‐15/10‐11, Saritanagari‐2, Off, Sinhagad Road, Pune ‐ 411 030, Maharashtra, India
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: complete response at 24 to 72 hours
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...were enrolled in each group. Patients were randomly assigned to one of the two prophylactic interventions by a computer‐generated number table. This prospective, randomized, double‐blinded, comparative study..."
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "this prospective, randomized, double‐blinded, comparative study was..."
Judgement comment: insufficient information on blinding
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blinded")
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, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear