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

Wu 2000.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 38

  • Age (mean ± SD, median (IQR), median (range)): 33.8 ± 7.8

  • Weight (mean ± SD, median (IQR), median (range)): 63 ± 12.8

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 31.58/26.32

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane and/or enflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 60

  • Use of perioperative opioids (if yes, which?): intraoperative opioids (100%), postoperative opioids (79%) (50 µg to 350 µg fentanyl or 1.0 mg to 1.5 mg alfentanil)

  • Type of surgery: laparoscopic gynaecological procedure


Droperidol

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 38

  • Age (mean ± SD, median (IQR), median (range)): 31.6 ± 6.9

  • Weight (mean ± SD, median (IQR), median (range)): 63.2 ± 12.8

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 36.84/34.21

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane and/or enflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 60

  • Use of perioperative opioids (if yes, which?): intraoperative opioids (100%), postoperative opioids (74%) (50 µg to 350 µg fentanyl or 1.0 mg to 1.5 mg alfentanil)

  • Type of surgery: laparoscopic gynaecological procedure


Ondansetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 37

  • Age (mean ± SD, median (IQR), median (range)): 33.1 ± 5.0

  • Weight (mean ± SD, median (IQR), median (range)): 60.5 ± 11.8

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 35.14/37.84

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane and/or enflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 59

  • Use of perioperative opioids (if yes, which?): intraoperative opioids (100%), postoperative opioids (81%) (50 µg to 350 µg fentanyl or 1.0 mg to 1.5 mg alfentanil)

  • Type of surgery: laparoscopic gynaecological procedure


Droperidol + ondansetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 39

  • Age (mean ± SD, median (IQR), median (range)): 32.9 ± 7.1

  • Weight (mean ± SD, median (IQR), median (range)): 62.6 ± 11.4

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 25.64/48.72

  • Type of general anaesthesia: inhalational anaesthesia (N₂O, isoflurane and/or enflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 60

  • Use of perioperative opioids (if yes, which?): intraoperative opioids (100%), postoperative opioids (67%) (50 µg to 350 µg fentanyl or 1.0 mg to 1.5 mg alfentanil)

  • Type of surgery: laparoscopic gynaecological procedure


Included criteria: ASA I to III, female outpatients scheduled to undergo elective laparoscopic gynaecological procedure under general anaesthesia, 16 to 65 years of age
Excluded criteria: laboratory or clinical evidence of cardiovascular, haematologic, pulmonary, renal, hepatic, neurological, or endocrine abnormalities; pregnancy; morbid obesity (those > 25% above ideal body weight); history of substance abuse; antiemetic or psychoactive medication within 24 hours before surgery; previous allergic reaction to serotonin antagonists; need for a nasogastric tube postoperatively
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (non‐smoker): unclear; (history of motion sickness): yes
Interventions Intervention characteristics
Placebo

  • Dose: saline

  • Time point of administration: upon induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 26% (dimenhydrinate 25 mg IV, metoclopramide 5 mg to 10 mg IV, ondansetron 4 mg IV)


Droperidol

  • Dose: 1.25 mg

  • Time point of administration: upon induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 16% (dimenhydrinate 25 mg IV, metoclopramide 5 mg to 10 mg IV, ondansetron 4 mg IV)


Ondansetron

  • Dose: 4 mg

  • Time point of administration: upon induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 30% (dimenhydrinate 25 mg IV, metoclopramide 5 mg to 10 mg IV, ondansetron 4 mg IV)


Droperidol + ondansetron

  • Dose: droperidol 1.25 mg, ondansetron 4 mg

  • Time point of administration: upon induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 3% (dimenhydrinate 25 mg IV, metoclopramide 5 mg to 10 mg IV, ondansetron 4 mg IV)
Outcomes PONV (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: supported by St. Michael’s Hospital Health Science Research Center, Toronto and in part by Glaxo, Inc. of Canada, Mississauga, Ontario, Canada
Country: Canada
Setting: outpatients, single‐centre
Author's name: Susan Belo
Institution: Department of Anaesthesia, St. Michael’s Hospital, Toronto, Ontario, Canada
Email: belos@smh.toronto.on.ca
Address: Department of Anaesthesia, St. Michael’s Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8 Canada
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "upon consent, each patient was randomized to one of four intravenous treatment categories"
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: "in this way, the anesthesiologist, study investigator, patient, operating room attendants, and recovery room nurses, were all blinded to the identity of the prophylactic treatment"
Quote: "each of these therapy medications was prepared by either the operating room pharmacist (not otherwise involved in the study) or by the research coordinator, and presented to the attending anesthesiologist"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "in this way, the anesthesiologist, study investigator, patient, operating room attendants, and recovery room nurses, were all blinded to the identity of the prophylactic treatment"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "there were eight study patients (two from the placebo group, three from the ondansetron group, two from the droperidol group, and one from the combination group) excluded from the study because they were inadvertently given thiopentol for induction of anesthesia. Thiopentol has been known to cause post‐operative nausea and vomiting. 2 0 Three study patients (one in the droperidol group, one in the ondansetron group, and one in the combination group) were admitted due to surgical complications unrelated to the study"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias High risk Quote: "no differences in demographic data among the four treatment groups in regards to age, height, weight, history of PONV after previous general anesthesia, duration of anesthesia, and history of motion sickness were found (Table I). There were also no differences among study groups in administration of midazolam, opioids given intraoperatively and post‐ operatively, all known to have anti‐emetic or emetic properties. However, the combination group did receive more nitrous oxide 70% than the other groups (Table II) which may lead to increased PONV"
Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (non‐smoker): unclear; (history of motion sickness): yes