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

Blitz 2012.

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

  • Enrolled (n): ‐

  • Randomized (n): 59

  • Received treatment (n): NA

  • Analysed (n): 59

  • Age (mean ± SD, median (IQR), median (range)): 35.2 ± 8.8

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

  • BMI (mean ± SD, median (IQR), median (range)): 37.8 ± 11.5

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 81.36

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

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

  • Use of perioperative opioids (if yes, which?): fentanyl during anaesthesia

  • Type of surgery: laparoscopic abdominal or gynaecological surgery


Palonosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 59

  • Received treatment (n): NA

  • Analysed (n): 59

  • Age (mean ± SD, median (IQR), median (range)): 36.2 ± 8.1

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

  • BMI (mean ± SD, median (IQR), median (range)): 36.6 ± 9.9

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 88.14

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

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

  • Use of perioperative opioids (if yes, which?): fentanyl during anaesthesia

  • Type of surgery: laparoscopic abdominal or gynaecological surgery


Included criteria: ASA I and II, 3 or more risk factors for PONV, scheduled to undergo elective outpatient laparoscopic abdominal or gynaecological surgery under general anaesthesia
Excluded criteria: pregnant or nursing mothers, received antiemetics within 24 hours of surgery, experienced retching or vomiting within 24 hours before surgery, on long‐term steroid therapy, were immunocompromised, documented allergy to 5‐HT3 receptor antagonists or dexamethasone
Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Palonosetron + dexamethasone
  • Dose: palonosetron 0.075 mg, dexamethasone 8 mg

  • Time point of administration: immediately after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): at the discretion of the patient's anaesthesiologist (no 5‐HT3 receptor antagonists)


Palonosetron
  • Dose: 0.075 mg

  • Time point of administration: immediately after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): at the discretion of the patient's anaesthesiologist (no 5‐HT3 receptor antagonists)

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

Identification Sponsorship source: funding provided by Eisai Inc.
Country: USA
Setting: outpatient, single‐centre
Author's name: Jeanna D. Blitz
Institution: Department of Anesthesiology, New York University Langone Medical Centre, New York
Email: jeanna.viola@nyumc.org
Address: Department of Anesthesiology, New York University Langone Medical Centre, 550 1st Avenue RR 605, New York, NY 10016
Duration of study: NA
Language: English
Study's primary outcome: complete response
Trial registry number: NCT00952133
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: quote: "were randomized". 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 Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT00952133 (retrospective registration)
Other bias Unclear risk Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear