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

Dsouza 2011.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Dexamethasone (4 mg group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 31

  • Received treatment (n): NA

  • Analysed (n): 31

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

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA/0

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

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

  • Use of perioperative opioids (if yes, which?): 2 μg/kg of fentanyl for induction, 1.5 mg/kg tramadol as rescue analgesia

  • Type of surgery: laparoscopic gynaecological surgery


Dexamethasone (8 mg group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 31

  • Received treatment (n): NA

  • Analysed (n): 30

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

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA/0

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

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

  • Use of perioperative opioids (if yes, which?): 2 μg/kg of fentanyl for induction, 1.5 mg/kg tramadol as rescue analgesia

  • Type of surgery: laparoscopic gynaecological surgery


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 31

  • Received treatment (n): NA

  • Analysed (n): 31

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

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

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

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

  • Use of perioperative opioids (if yes, which?): 2 μg/kg of fentanyl for induction, 1.5 mg/kg tramadol as rescue analgesia

  • Type of surgery: laparoscopic gynaecological surgery


Included criteria: women aged 20 to 60 years with ASA grade I or II, scheduled for gynaecological laparoscopic surgery (e.g. laparoscopic ovarian cystectomy, adhesiolysis, Burch suspension, ovarian drilling, myomectomy, tubal reanastomosis, tubal patency test) under general anaesthesia with endotracheal intubation
Excluded criteria: physical status ASA III or above; lactating or menstruating; taking any medication, including corticosteroids (except oral contraceptive pills); history of motion sickness; had not complied with 6 hours of preoperative fasting; gastrointestinal disorders; had received opioids, antiemetics, or steroids in the previous month; had previous hypersensitivity to these drugs
Pretreatment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, history of motion sickness): no; (history of PONV, duration of anaesthesia, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Dexamethasone (4 mg group)
  • Dose: 4 mg

  • Time point of administration: 5 minutes before induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 0% (metoclopramide 10 mg)


Dexamethasone (8 mg group)
  • Dose: 8 mg

  • Time point of administration: 5 minutes before induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 6.7% (metoclopramide 10 mg)


Ondansetron 4 mg
  • Dose: 4 mg

  • Time point of administration: 5 minutes before induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 16.1% (metoclopramide 10 mg)

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


Vomiting (0 to 3 hours)
  • Outcome type: dichotomous outcome


Vomiting (3 to 6 hours)
  • Outcome type: dichotomous outcome


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


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


Headache (overall, exact 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: NA
Country: India
Setting: inpatient, single‐centre
Author's name: Nita D'souza
Institution: Department of Anesthesia and Intensive care, All India Institute of Medical Sciences, New Delhi, India
Email: drnita610@yahoo.com
Address: Doctor's Hostel, Room No. 2, JPNA Trauma Centre, AIIMS, New Delhi‐110029, India. Tel.: +91 9953008488
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: "the participants underwent simple randomization into 3 groups"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "open‐label"
Judgement comment: study was not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Judgement comment: study was not blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "among the 93 patients enrolled, 1 patient from the Dexa 8 group was excluded because she failed to comply with the nil‐per‐mouth criterion"
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 (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, history of motion sickness): no; (history of PONV, duration of anaesthesia, non‐smoker, perioperative opioids): unclear