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

Rothenberg 1998.

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

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 47

  • Age (mean ± SD, median (IQR), median (range)): 32 (17 to 45)

  • Weight (mean ± SD, median (IQR), median (range)): 66 (45 to 95)

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 8.5/14.9

  • Type of general anaesthesia: combined anaesthesia (N₂O, propofol)

  • Duration of anaesthesia or surgery (in min; as mean or median): 40

  • Use of perioperative opioids (if yes, which?): 2.9 mg morphine, 1.5 µg/kg fentanyl

  • Type of surgery: gynaecological laparoscopy


Dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 48

  • Age (mean ± SD, median (IQR), median (range)): 32 (18 to 48)

  • Weight (mean ± SD, median (IQR), median (range)): 65 (47 to 100)

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 6.3/14.6

  • Type of general anaesthesia: combined anaesthesia (N₂O, propofol)

  • Duration of anaesthesia or surgery (in min; as mean or median): 41.5

  • Use of perioperative opioids (if yes, which?): 3.4 mg morphine, 1.5 µg/kg fentanyl

  • Type of surgery: gynaecological laparoscopy


Included criteria: ASA I or II, requiring outpatient gynaecological laparoscopy
Excluded criteria: currently receiving antiemetic or corticosteroid therapy; history of immunosuppression, peptic ulcer disease, diabetes mellitus, hypertension, recent tuberculosis, Cushing’s syndrome, or cataracts
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear
Interventions Intervention characteristics
Droperidol
  • Dose: 0.02 mg/kg

  • Time point of administration: before abdominal incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide, ondansetron, prochlorperazine, droperidol, or ephedrine, alone or in combination


Dexamethasone
  • Dose: 0.17 mg/kg

  • Time point of administration: before abdominal incision

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide, ondansetron, prochlorperazine, droperidol, or ephedrine, alone or in combination

Outcomes Vomiting (PACU)
  • Outcome type: dichotomous outcome


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


PONV (0 to 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: NA
Country: USA
Setting: outpatient, single‐centre
Author's name: David M. Rothenberg
Institution: Department of Anesthesiology, Rush‐Presbyterian‐St. Luke's Medical Center, Chicago, Illinois, USA
Email: NA
Address: Department of Anesthesiology, Rush‐Presbyterian‐St. Luke's Medical Center, 1653 W. Congress Parkway, Chicago, Illinois, USA
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the purpose of this randomized..."
Judgement comment: no information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "unlabeled numbered aliquots of the study drugs were prepared in equal volumes by an operating room pharmacist without knowledge of the study design"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "within 24 h a blinded observer telephoned each patient to inquire about additional postoperative complications"
Quote: "...by a nurse not directly participating in the study"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "five patients (5%) were excluded from data analysis due to the need to perform surgical laparotomy (2 patients) and failure to achieve telephone contact (3 patients). Of the remaining 95 patients, 47 were assigned to the droperidol group, and 48 were assigned to the dexamethasone group"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "...assigned to the dexamethasone group. There were no differences between the two groups in relationship to patient age, weight, prior episodes of PONV, preoperative history of motion sickness, timing of menses, duration of surgery, amount of IV fluid or vecuronium administered or propofol maintenance dosage (Table 1)..."
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear