Study characteristics |
Methods |
Study design: randomized controlled trial Study grouping: 4 groups, monoprophylaxis |
Participants |
Baseline characteristics Droperidol
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): 15
Received treatment (n): NA
Analysed (n): 15
Age (mean ± SD, median (IQR), median (range)): 28 ± 7
Weight (mean ± SD, median (IQR), median (range)): 58 ± 6
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): NA/NA/0/0
Gender (female in %): NA
Non‐smoker (%): NA
History of PONV/motion sickness (%): 0/NA
Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 207
Use of perioperative opioids (if yes, which?): 359 µg fentanyl intraoperative
Type of surgery: head and neck surgery
Diphenidol
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): 15
Received treatment (n): NA
Analysed (n): 15
Age (mean ± SD, median (IQR), median (range)): 27 ± 9
Weight (mean ± SD, median (IQR), median (range)): 59 ± 7
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): NA/NA/0/0
Gender (female in %): NA
Non‐smoker (%): NA
History of PONV/motion sickness (%): 0/NA
Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 192
Use of perioperative opioids (if yes, which?): 303 µg fentanyl intraoperative
Type of surgery: head and neck surgery
Metoclopramide
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): 15
Received treatment (n): NA
Analysed (n): 15
Age (mean ± SD, median (IQR), median (range)): 29 ± 14
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 %): NA
Non‐smoker (%): NA
History of PONV/motion sickness (%): 0/NA
Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 249
Use of perioperative opioids (if yes, which?): 456 µg fentanyl intraoperative
Type of surgery: head and neck surgery
Placebo
Assessed for eligibility (n): ‐
Enrolled (n): ‐
Randomized (n): 15
Received treatment (n): NA
Analysed (n): 15
Age (mean ± SD, median (IQR), median (range)): 30 ± 11
Weight (mean ± SD, median (IQR), median (range)): 61 ± 8
BMI (mean ± SD, median (IQR), median (range)): NA
ASA I/II/III/IV (n): NA/NA/0/0
Gender (female in %): NA
Non‐smoker (%): NA
History of PONV/motion sickness (%): 0/NA
Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)
Duration of anaesthesia or surgery (in min; as mean or median): 155
Use of perioperative opioids (if yes, which?): 340 µg fentanyl intraoperative
Type of surgery: head and neck surgery
Included criteria: both sexes, 18 to 60 years of age, scheduled for elective surgery of the head and neck (maxillofacial surgery, plastic surgery, reconstructive surgery), ASA I or II Excluded criteria: old history of nausea and postoperative vomiting, obese, women, pregnant or in the menstrual period, pathology leading to vomiting Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (history of PONV): no; (gender, non‐smoker, history of motion sickness): unclear; (perioperative opioids, duration of anaesthesia): yes |
Interventions |
Intervention characteristics Droperidol
Dose: 15 µg/kg to 20 µg/kg
Time point of administration: 30 minutes before end of anaesthetic procedure
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
Diphenidol
Dose: 150 µg/kg
Time point of administration: 30 minutes before end of anaesthetic procedure
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
Metoclopramide
Dose: 150 µg/kg
Time point of administration: 30 minutes before end of anaesthetic procedure
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
Placebo
Dose: 3 ml saline
Time point of administration: 30 minutes before end of anaesthetic procedure
Route of administration: IV
Rescue antiemetics (if yes, which?): NA
|
Outcomes |
Vomiting (0 to 4 hours)
|
Identification |
Sponsorship source: NA Country: Mexico Setting: inpatient, single‐centre Author's name: Rebeca E. Pérez‐Ascencio Institution: Departemento de Anestesiología del Hospital de Escpecialidades del Centro Médico La Raza Email: NA Address: Departemento de Anestesiología del Hospital de Escpecialidades del Centro Médico La Raza, Instituto Mexicano del Seguro social (IMSS), México D.F. Duration of study: NA Language: Spanish (translated by Insa Backhaus) 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 |
Judgement comment: quote: "a random population of 60 patients ..." (translated) 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: no statement on blinding of participants and personnel |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: no statement on blinding of outcome assessor |
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 |
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (history of PONV): no; (gender, non‐smoker, history of motion sickness): unclear; (perioperative opioids, duration of anaesthesia): yes |