| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 5 groups, monoprophylaxis, dose‐finding study |
| Participants |
Baseline characteristics
Domperidone (5 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 36 Received treatment (n): NA Analysed (n): 36 Age (mean ± SD, median (IQR), median (range)): 40 ± 13 Weight (mean ± SD, median (IQR), median (range)): 61 ± 10 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: balanced anaesthesia (N₂O, fentanyl) Duration of anaesthesia or surgery (in min; as mean or median): 94 Use of perioperative opioids (if yes, which?): 0.15 mg/kg oxycodone as premedication, 23 mg oxycodone postoperatively, 0.29 mg fentanyl intraoperative Type of surgery: orthopaedic surgery
Domperidone (10 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 36 Received treatment (n): NA Analysed (n): 36 Age (mean ± SD, median (IQR), median (range)): 42 ± 13 Weight (mean ± SD, median (IQR), median (range)): 64 ± 10 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: balanced anaesthesia (N₂O, fentanyl) Duration of anaesthesia or surgery (in min; as mean or median): 78 Use of perioperative opioids (if yes, which?): 0.15 mg/kg oxycodone as premedication, 24 mg oxycodone postoperatively, 0.27 mg fentanyl intraoperative Type of surgery: orthopaedic surgery
Droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 36 Received treatment (n): NA Analysed (n): 36 Age (mean ± SD, median (IQR), median (range)): 43 ± 14 Weight (mean ± SD, median (IQR), median (range)): 64 ± 12 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: balanced anaesthesia (N₂O, fentanyl) Duration of anaesthesia or surgery (in min; as mean or median): 107 Use of perioperative opioids (if yes, which?): 0.15 mg/kg oxycodone as premedication, 22 mg oxycodone postoperatively, 0.33 mg fentanyl intraoperative Type of surgery: orthopaedic surgery
Metoclopramide
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 37 Received treatment (n): NA Analysed (n): 37 Age (mean ± SD, median (IQR), median (range)): 41 ± 14 Weight (mean ± SD, median (IQR), median (range)): 61 ± 10 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: balanced anaesthesia (N₂O, fentanyl) Duration of anaesthesia or surgery (in min; as mean or median): 85 Use of perioperative opioids (if yes, which?): 0.15 mg/kg oxycodone as premedication, 24 mg oxycodone postoperatively, 0.25 mg fentanyl intraoperative Type of surgery: orthopaedic surgery
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 40 Received treatment (n): NA Analysed (n): 40 Age (mean ± SD, median (IQR), median (range)): 41 ± 13 Weight (mean ± SD, median (IQR), median (range)): 62 ± 10 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: balanced anaesthesia (N₂O, fentanyl) Duration of anaesthesia or surgery (in min; as mean or median): 95 Use of perioperative opioids (if yes, which?): 0.15 mg/kg oxycodone as premedication, 20 mg oxycodone postoperatively, 0.31 mg fentanyl intraoperative Type of surgery: orthopaedic surgery
Included criteria: women undergoing elective orthopaedic surgery, ASA I or II, during the 2 weeks before the operation had not taken any drugs with an antiemetic action
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker): unclear; (duration of anaesthesia,perioperative opioids): yes |
| Interventions |
Intervention characteristics
Domperidone (5 mg group)
Dose: 5 mg Time point of administration: 5 minutes before end of surgery Route of administration: IV Rescue antiemetics (if yes, which?): domperidone 5 mg IM, droperidol 1.25 mg IM
Domperidone (10 mg group)
Dose: 10 mg Time point of administration: 5 minutes before end of surgery Route of administration: IV Rescue antiemetics (if yes, which?): domperidone 10 mg IM, droperidol 1.25 mg IM
Droperidol
Dose: 1.25 mg Time point of administration: 5 minutes before end of surgery Route of administration: IV Rescue antiemetics (if yes, which?): droperidol 1.25 mg IM
Metoclopramide
Dose: 10 mg Time point of administration: 5 minutes before end of surgery Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 10 mg IM, droperidol 1.25 mg
Placebo
Dose: saline Time point of administration: 5 minutes before end of surgery Route of administration: IV Rescue antiemetics (if yes, which?): droperidol 1.25 mg
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: Orion Pharmaceutical Company provided the drugs
Country: Finland
Setting: inpatient, single‐centre
Author's name: K. Korttila
Institution: Department of Anesthesia, Helsinki University Central Hospital
Email: NA
Address: Department of Anesthesia, University of Iowa Hospitals and Clinics, Iowa City, IA 52242
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: "a double‐blind randomized fashion"
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 |
Judgement comment: insufficient information on blinding ("double‐blind") |
| 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: 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 |
High risk |
Quote: "the slightly longer duration of anesthesia, as well as the slightly greater amount of fentanyl, in patients given droperidol should have contributed to a higher incidence of emetic sequelae than that associated with shorter duration of anesthesia and a smaller amount of fentanyI.2*3"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker): unclear; (duration of anaesthesia, perioperative opioids): yes |
