| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis |
| Participants |
Baseline characteristics
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 51 Received treatment (n): NA Analysed (n): 51 Age (mean ± SD, median (IQR), median (range)): 35.7 ± 1.6 Weight (mean ± SD, median (IQR), median (range)): 59.0 ± 1.6 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 (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.05 mg if < 50 kg, 0.1 mg if > 50 kg (for induction) Type of surgery: minor gynaecological surgery (dilatation, curettage, other)
Domperidone
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 35.8 ± 1.6 Weight (mean ± SD, median (IQR), median (range)): 60.8 ± 1.5 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 (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.05 mg if < 50 kg, 0.1 mg if > 50 kg (for induction) Type of surgery: minor gynaecological surgery (dilatation, curettage, other)
Droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 48 Age (mean ± SD, median (IQR), median (range)): 34.7 ± 2.1 Weight (mean ± SD, median (IQR), median (range)): 61.5 ± 2.2 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 (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.05 mg if < 50 kg, 0.1 mg if > 50 kg (for induction) Type of surgery: minor gynaecological surgery (dilatation, curettage, other)
Metoclopramide
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 36.8 ± 2.0 Weight (mean ± SD, median (IQR), median (range)): 59.1 ± 2.0 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 (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.05 mg if < 50 kg, 0.1 mg if > 50 kg (for induction) Type of surgery: minor gynaecological surgery (dilatation, curettage, other)
Included criteria: women, ASA grade I or II, 16 to 70 years of age, undergoing minor gynaecological surgery as day‐cases in the same unit
Excluded criteria: already receiving medication with antiemetic properties, would receive ergometrine during the procedure
Pretreatment: baseline characteristics (age, ASA, weight): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear |
| Interventions |
Intervention characteristics
Placebo
Dose: saline Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Domperidone
Dose: 20 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Droperidol
Dose: 2.5 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
Metoclopramide
Dose: 10 mg Time point of administration: immediately before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM
|
| Outcomes |
Vomiting (0 to 4 hours)
Extrapyramidal symptoms (0 to 4 hours)
Sedation/drowsiness (0 to 4 hours)
Adverse events (general notes in the publication, 4 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: England
Setting: outpatient, single‐centre
Author's name: T.H. Madej
Institution: University Department of Anaesthesia, St James' s University Hospital
Email: NA
Address: University Department of Anaesthesia, St James's University Hospital, Beckett Street, Leeds LS9 7TF
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: "immediately before the induction of anaesthesia, each patient received one of the study drugs, chosen in a double‐blind, randomized fashion, i.v."
Judgement comment: no further information on randomization method provided |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "the drugs were presented in numbered, identical 4‐ml ampoules containing one of the following: domperidone 20 mg, droperidol 2.5 mg, metoclopramide 10 mg or placebo (saline)"
Judgement comment: insufficient information on blinding ("double‐blind") |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "...of etomidate i.v., as necessary. After operation the patients were assessed by trained members of the nursing staff. They were observed..."
Judgement comment: insufficient information on blinding ("double‐blind") |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "two hundred and one patients were involved in the study initially; two were excluded from the droperidol group because ergometrine was given" |
| 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 (age, ASA, weight): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear |
