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

Watts 1996.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 59

  • Age (mean ± SD, median (IQR), median (range)): 30.5 ± 5.68

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 27/25

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 20 to 30

  • Use of perioperative opioids (if yes, which?): 1.5 µg/kg fentanyl at induction, 9.4 mg morphine postoperative

  • Type of surgery: laparoscopic procedure


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 55

  • Age (mean ± SD, median (IQR), median (range)): 30.9 ± 2.89

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 20/20

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 20 to 30

  • Use of perioperative opioids (if yes, which?): 1.5 µg/kg fentanyl at induction, 8.7 mg morphine postoperative

  • Type of surgery: laparoscopic procedure


Cyclizine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 53

  • Age (mean ± SD, median (IQR), median (range)): 30.3 ± 7.06

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 23/28

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 20 to 30

  • Use of perioperative opioids (if yes, which?): 1.5 µg/kg fentanyl at induction, 8.4 mg morphine postoperative

  • Type of surgery: laparoscopic procedure


Included criteria: women presenting for elective laparoscopic procedure on a day‐stay basis
Excluded criteria: pregnant, had taken any opiate or antiemetic in the preceding 24 hours, history of hypersensitivity to any of the trial agents, on assessment were deemed to be better served by an anaesthetic different from the standard technique (obesity, reflux, difficult airway)
Pretreatment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: immediately following cannula insertion

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM


Metoclopramide
  • Dose: 10 mg

  • Time point of administration: immediately following cannula insertion

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM


Cyclizine
  • Dose: 50 mg

  • Time point of administration: immediately following cannula insertion

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM

Outcomes PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome


Extrapyramidal symptoms (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: New Zealand
Setting: outpatient, single‐centre
Author's name: S.A. Watts
Institution: Palmerston North Hospital, Palmerston North, New Zealand
Email: NA
Address: Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes Two studies (1 non‐randomized pilot study, 1 RCT)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the second phase was a randomized, double‐blind comparison of the efficacy of the three study antiemetics"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Quote: "all test agents were supplied to the administering anaesthetist in capped and coded syringes containing 2 ml of colourless liquid"
Judgement comment: insufficient information on allocation concealment and time point of randomization
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "all test agents were supplied to the administering anaesthetist in capped and coded syringes containing 2 ml of colourless liquid"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "...hours postoperatively and at time of discharge from the day‐stay unit (usually four to six hours post operation), by the attending nursing staff. Scores at 24 hours were attained by phone or standard questionnaire via return mail by the investigator"
Judgement comment: no information on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "...166 making up the comparative trial population. Of the patients in the comparative trial, 54 were given metoclopramide (Group M), 59 received ondansetron (Group O) and 53 cyclizine (Group C)"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "...similar in the three groups for mean patient age, day of menstrual cycle and type of operation. Distribution of patients with a past history of motion sickness or previous PONV was comparable between groups and likewise there was no difference of significance in the distribution of operative procedures"
Judgement comment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear