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

Gan 2004.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 26

  • Received treatment (n): NA

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 47 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 74 ± 18

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

  • ASA I/II/III/IV (n): 6/16/3/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 36

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 199

  • Use of perioperative opioids (if yes, which?): 343 µg fentanyl intraoperative, 76 µg postoperative fentanyl

  • Type of surgery: major breast surgery


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): NA

  • Analysed (n): 24

  • Age (mean ± SD, median (IQR), median (range)): 46 ± 12

  • Weight (mean ± SD, median (IQR), median (range)): 77 ± 17

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

  • ASA I/II/III/IV (n): 7/16/1

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 46

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 222

  • Use of perioperative opioids (if yes, which?): 376 µg fentanyl intraoperative, 91 µg postoperative fentanyl

  • Type of surgery: major breast surgery


Included criteria: undergoing major breast surgery
Excluded criteria: pregnant, experiencing menstrual symptoms, using a permanent cardiac pacemaker, had previous experience with acupuncture therapies, had received any antiemetic medication or had experienced nausea, vomiting, or retching within 24 hours of surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): dexamethasone 8 mg; 28%


Placebo
  • Dose: saline

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): dexamethasone 8 mg; 54%

Outcomes Vomiting (0 to 2 hours)
  • Outcome type: dichotomous outcome


Vomiting (2 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: USA
Setting: outpatient, single‐centre
Author's name: Tong J. Gan
Institution: Departments of Anesthesiology and Plastic Surgery, Duke University Medical Center, Durham, North Carolina, USA
Email: gan00001@mc.duke.edu
Address: Department of Anesthesiology, Duke University Medical Center, Box 3094, Durham, NC 2771, USA
Duration of study: NA
Language: English
Study's primary outcome: incidence of nausea
Trial registry number: NA
Notes Two out of 3 groups relevant (electro‐acupoint stimulation)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization was achieved using a random number generator"
Allocation concealment (selection bias) Unclear risk Quote: "in a sealed envelope technique..."
Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the anesthesiologists and care providers were blinded to the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "postoperative data were collected by a separate research nurse not involved in the preoperative or intraoperative management of patients"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "seventy‐seven patients were enrolled in the study. One patient from the O group did not have her scheduled surgery and one patient from the P group withdrew from participation before the administration of study procedure. Seventy‐five patients completed the study"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "there was no difference in patient demographics among the groups..."
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear