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

Larsson 1988.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Dixyrazine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 39 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 75 ± 14

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 60

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (fentanyl, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 129

  • Use of perioperative opioids (if yes, which?): 3.9 µg/kg/h fentanyl intraoperative, pethidine postoperative

  • Type of surgery: abdominal, minor orthopaedic, thyroid, mammary


Scopolamine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 29

  • Age (mean ± SD, median (IQR), median (range)): 39 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 70 ± 12

  • 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: balanced anaesthesia (fentanyl, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 148

  • Use of perioperative opioids (if yes, which?): 3.9 µg/kg/h fentanyl intraoperative, pethidine postoperative, morphine 0.15 mg/kg

  • Type of surgery: abdominal, minor orthopaedic, thyroid, mammary


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 26

  • Age (mean ± SD, median (IQR), median (range)): 40 ± 13

  • Weight (mean ± SD, median (IQR), median (range)): 68 ± 15

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 53

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (fentanyl, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 128

  • Use of perioperative opioids (if yes, which?): 4.7 µg/kg/h fentanyl intraoperative, pethidine postoperative

  • Type of surgery: abdominal, minor orthopaedic, thyroid, mammary


Included criteria: 20 to 60 years of age; ASA I or II; scheduled for abdominal, minor orthopaedic, thyroid, or mammary surgery expected to last at least 1 hour; no patient was on continuous sedative or analgesic medication
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes
Interventions Intervention characteristics
Dixyrazine
  • Dose: 0.5 mg/kg

  • Time point of administration: 1 hour before anaesthesia induction

  • Route of administration: IM

  • Rescue antiemetics (if yes, which?): droperidol


Scopolamine
  • Dose: scopolamine 0.0065 mg/kg, morphine 0.15 mg/kg

  • Time point of administration: 1 hour before anaesthesia induction

  • Route of administration: IM

  • Rescue antiemetics (if yes, which?): droperidol


Placebo
  • Dose: saline

  • Time point of administration: 1 hour before anaesthesia induction

  • Route of administration: IM

  • Rescue antiemetics (if yes, which?): droperidol

Outcomes Sedation/drowsiness (at 24 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 6 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: NA
Country: Sweden
Setting: NA, single‐centre
Author's name: Sylvia Larsson
Institution: Department of Anesthesiology, University Hospital, Lund, Sweden
Email: NA
Address: NA
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomly divided into three groups with 30 patients each"
Judgement comment: 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 Quote: "in equal volume and in a double‐blind fashion"
Judgement comment: insufficient information on blinding
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: quote: "two patients excluded because of thyrotoxic symptoms before induction of anaesthesia. 8 patients were later excluded because of following reasons: delays in operating room schedule, major surgical bleeding, anaesthesia >1 h, reoperation"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias High risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes