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

Yeo 2009.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 45.2 ± 6.4

  • Weight (mean ± SD, median (IQR), median (range)): 57.6 ± 8.3

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): 0

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 175.8

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: middle ear surgery (tympanoplasty or mastoidectomy)


Dexamethasone

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 45.8 ± 9.1

  • Weight (mean ± SD, median (IQR), median (range)): 59.5 ± 10.0

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): 0

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 189.1

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: middle ear surgery (tympanoplasty or mastoidectomy)


Included criteria: ASA I or II, non‐smoking, female, 19 to 62 years of age, undergoing middle ear surgery (tympanoplasty or mastoidectomy)
Excluded criteria: gastrointestinal disorder; history of previous PONV or motion sickness; had received antiemetic medication within 24 hours before surgery; had received steroid, opioid, benzodiazepine, or antipsychotic medication; pregnant or menstruating
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Placebo

  • Dose: 2 × 2 mL saline

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 35% (ondansetron)


Dexamethasone

  • Dose: 10 mg dexamethasone, saline

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 20% (ondansetron)
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)

  • Outcome type: dichotomous outcome


Postoperative wound infection (during hospital stay)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (during hospital stay)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)

  • Outcome type: general notes on side effects
Identification Sponsorship source: no sponsorship
Country: Korea
Setting: inpatient, single‐centre
Author's name: Young Hoon Jeon
Institution: Department of Anesthesiology, Kyungpook National University Hospital, Daegue, Republic of Korea
Email: jeon68@knu.ac.kr
Address: Department of Anesthesiology, Kyungpook National University Hospital, 200 Donduk‐ro Jung‐gu, Daegue, 700‐721, Republic of Korea
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: incidence of PONV
Notes Two out of 3 groups relevant (midazolam)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "according to a computer‐generated random number table, patients were randomly allocated to one of three groups"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the randomized patient selection process and the identity of the drugs used in the study were blinded to the patients, the anesthesiologists present during surgery"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the randomized patient selection process and the identity of the drugs used in the study were blinded to the patients, the anesthesiologists present during surgery, and the investigators who collected the postoperative data"
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 Low risk Quote: "patient characteristics, duration of anesthesia and operation, surgical procedures, and duration of PACU stay were similar among the three groups (Table 1)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no