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

Ghosh 2011.

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

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 36.33 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 57.47 ± 8.25

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

  • ASA I/II/III/IV (n): 25/5/0/0

  • Gender (female in %): 90

  • 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): 59

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 1 µg/kg every 30 minutes, tramadol 100 mg IV

  • Type of surgery: laparoscopic cholecystectomy


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

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 35.03 ± 10.15

  • Weight (mean ± SD, median (IQR), median (range)): 56.67 ± 9.81

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

  • ASA I/II/III/IV (n): 25/5/0/0

  • Gender (female in %): 83

  • 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): 61.33

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 1 µg/kg every 30 minutes, tramadol 100 mg IV

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: ASA I and II, 18 to 60 years of age, weighing 40 to 70 kg, scheduled for elective laparoscopic surgery under general anaesthesia
Excluded criteria: pregnant or menstruating, gastrointestinal or renal disease, received cancer chemotherapy within past 4 weeks, emetogenic radiotherapy within past 8 weeks, had experienced nausea or vomiting, had taken antiemetic medication within 24 hours before surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Palonosetron
  • Dose: 0.075 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 0% (ondansetron 4 mg)


Palonosetron + dexamethasone
  • Dose: palonosetron 0.075 mg, dexamethasone 8 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 0% (ondansetron 4 mg)

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


Vomiting (0 to 2 hours)
  • Outcome type: dichotomous outcome


Vomiting (2 to 24 hours)
  • Outcome type: dichotomous outcome


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


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

Identification Sponsorship source: departmental funding only
Country: India
Setting: Inpatient, single‐centre
Author's name: Dr. Anirban Pal
Institution: Department of Anesthesiology, Calcutta National Medical College (CNMC), Kolkata, India
Email: pal.anirban1@gmail.com
Address: 43/6/5 Jheel Road, Kolkata ‐ 700 031, West Bengal, India
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) Low risk Quote: "the patients were randomly (computer‐generated numbers inserted into opaque envelope) allocated to two groups P and PD"
Allocation concealment (selection bias) Unclear risk Quote: "the patients were randomly (computer‐generated numbers inserted into opaque envelope) allocated to two groups P and PD..."
Judgement comment: not stated if envelopes were sequentially numbered and sealed (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "a consultant anesthesiologist who performed general anesthesia and used the study drug, was unaware of the type of study drug used and did not participate in the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "...paracetamol 1 g (100 ml). Patients were asked about nausea, vomiting, retching and any side‐effects, at 2, 6, 24, 48 h by an investigator. The investigator and the patients were blinded to the study drug used. The severity of PONV..."
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, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear