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

Schuh 1987.

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

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 48 ± 13.9

  • Weight (mean ± SD, median (IQR), median (range)): 71 ± 13.1

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 85

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 80

  • Use of perioperative opioids (if yes, which?): 0.33 mg intraoperative fentanyl, tramadol postoperative

  • Type of surgery: cholecystectomy


TTS‐Scopalamine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 50 ± 12.3

  • Weight (mean ± SD, median (IQR), median (range)): 70 ± 12.1

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 70

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 71

  • Use of perioperative opioids (if yes, which?): 0.35 mg intraoperative fentanyl, tramadol postoperative

  • Type of surgery: cholecystectomy


Included criteria: ASA I or II, cholecystolithiasis undergoing cholecystectomy under standardized balanced anaesthesia
Excluded criteria: over 70 years of age, glaucoma, micturition disturbance, intake of anticholinergics, history of psychiatric therapy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Droperidol (DHB)
  • Dose: 7.5 mg, placebo patch

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 15% (metoclopramide)


TTS‐Scopalamine
  • Dose: NA

  • Time point of administration: on the evening before surgery

  • Route of administration: transdermal

  • Rescue antiemetics (if yes, which?): 60% (metoclopramide)

Outcomes Vomiting (2 to 6 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, observation until the afternoon on the first postoperative day)
  • Outcome type: general notes on side effects

Identification Sponsorship source: NA
Country: Germany
Setting: inpatient, single‐centre
Author's name: Rainer Schuh
Institution: Anästhesieabteilung, Elisabethenstift, Darmstadt
Email: NA
Address: Anästhesieabteilung, Elisabethenstift, Landgraf‐Georg‐Straße 100, 6100 Darmstadt
Duration of study: 1985 to 1986
Language: German (2 German reviewers)
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) Low risk Quote: "Ppatienten wurden prospektiv mit einer Zufallszahlentabelle zwei Gruppen randomisiert zugeordnet. Mit..."
Judgement comment: random number table
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "tabelle zwei Gruppen randomisiert zugeordnet. Mit der Anwendung eines Placebopflasters in der DHB‐Gruppe wurde die Untersuchung einfach blind durchgeführt. Die angewendeten statistischen Methoden richteten"
Judgement comment: personnel was not blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement
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 Quote: "hinsichtlich der anthropometrischen Daten (Tab. 1) ergaben sich ‐ auch bei der Geschlechtsverteilung ‐ keine signifikanten Unterschiede"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear