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

Millar 1987.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 24 ± 0.9

  • Weight (mean ± SD, median (IQR), median (range)): 60 ± 1.3

  • 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 (%): 29/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 8

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: day‐case termination of pregnancy


Droperidol (0.25 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 48

  • Age (mean ± SD, median (IQR), median (range)): 23 ± 0.8

  • Weight (mean ± SD, median (IQR), median (range)): 61 ± 1.1

  • 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 (%): 47/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 8

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: day‐case termination of pregnancy


Droperidol (0.5 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 47

  • Age (mean ± SD, median (IQR), median (range)): 25 ± 1.0

  • Weight (mean ± SD, median (IQR), median (range)): 58 ± 1.9

  • 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 (%): 64/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 8

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: day‐case termination of pregnancy


Included criteria: 150 patients who presented for day‐case termination of pregnancy, over 16 years of age, assessed preoperatively as ASA I or II, not taking antiemetics or drugs with a possible interaction with droperidol
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear; (history of PONV): yes
Interventions Intervention characteristics
Placebo

  • Dose: sterile water

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

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


Droperidol (0.25 mg group)

  • Dose: 0.25 mg

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 8% (metoclopramide 10 mg)


Droperidol (0.5 mg group)

  • Dose: 0.5 mg

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 8% (metoclopramide 10 mg)
Outcomes Vomiting (0 to 2 hours)

  • Outcome type: dichotomous outcome


Vomiting (2 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (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: Australia
Setting: outpatient, single‐centre
Author's name: J.M. Millar
Institution: Nuffield Department of Anaesthetics and Radcliffe Infirmary, Victoria
Email: NA
Address: Radcliff Infirmary, Oxford OX2 6HE
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: "the patients were assigned randomly to one of three groups to receive intravenously either sterile water, droperidol 0.25 mg or droperidol 0.5 mg"
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 Low risk Quote: "pharmacy prepared identical, randomly numbered ampoules that contained the test dose in 0.5 ml"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "a direct enquiry about postoperative nausea and vomiting was made al this time, and questionnaires and prepaid envelopes were given to the patients with instructions that these should be completed 24 hours after discharge"
Quote: "the patients were assessed by an experienced anaesthetist and deemed fit for discharge if they were free from significant pain, sedation and nausea, had no surgical complications such as continued blood loss. and could dress themselves and walk steadily"
Judgement comment: insufficient information on blinding of recovery staff and anaesthetist who assessed the outcomes. For the 24 hour time point questionnaires were used
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "there was a 76% response to the questionnaire (Table 4)..."
Quote: "test for nonparametric data. The results of six patients were excluded from the trial due to noncompliance with the protocol. Thc characteristics..."
Judgement comment: all missing data before discharge with reasons explained. High rate of loss of response to the questionnaire at 24 hours (24%)
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias High risk Quote: "the characteristics of the three groups were similar. There were no significant differences in age, weight or gestation. Significantly fewer patients in the group that received droperidol 0.5 mg had had a previous anaesthetic, and a significantly greater proportion of patients in both droperidol groups gave a history of nausea and vomiting after general anaesthesia"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear; (history of PONV): yes