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

Akin 2005.

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

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): NA

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 34.4 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 73.3 ± 12.9

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 57.14

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 181

  • Use of perioperative opioids (if yes, which?): 1 µg/kg fentanyl for induction

  • Type of surgery: tympanomastoid surgery


Tropisetron + dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): NA

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 33.2 ± 13.8

  • Weight (mean ± SD, median (IQR), median (range)): 67 ± 10

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 60

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 173

  • Use of perioperative opioids (if yes, which?): 1 µg/kg fentanyl for induction

  • Type of surgery: tympanomastoid surgery


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 35

  • Received treatment (n): NA

  • Analysed (n): 35

  • Age (mean ± SD, median (IQR), median (range)): 31.2 ± 12.7

  • Weight (mean ± SD, median (IQR), median (range)): 73.3 ± 14.6

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 57.14

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 165

  • Use of perioperative opioids (if yes, which?): 1 µg/kg fentanyl for induction

  • Type of surgery: tympanomastoid surgery


Included criteria: ASA I and II, 18 to 65 years of age, scheduled for elective tympanomastoid surgery
Excluded criteria: gastrointestinal disorders, intake of antiemetics or centrally acting medication within 24 hours before surgery, menstruation, body weight exceeding optimal weight > 50%, therapy with corticosteroids or immunosuppressives
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Tropisetron
  • Dose: 5 mg

  • Time point of administration: at induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 11.4% (metoclopramide 10 mg IV)


Tropisetron + dexamethasone
  • Dose: tropisetron 5 mg, dexamethasone 5 mg

  • Time point of administration: at induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 8.6% (metoclopramide 10 mg IV)


placebo
  • Dose: NaCl

  • Time point of administration: at induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 40% (metoclopramide 10 mg IV)

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


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


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

Identification Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Aynur Akin
Institution: Erciycs Universitcsi Tip Fakultesi Anesteziyoloji ve Reanimasyon Anabilim Dah, Kayseri
Email: aaynur@erciyes.edu.tr
Address: Alpaslan Mah. Kandil Sok. Bezciler Sitesi 3. Blok No:6 K:6 D:11.38030‐Melikgazi‐Kayseri
Duration of study: NA
Language: Turkish (translated by Emine Yesil)
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: no information on sequence generation provided ("randomized")
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding provided ("double‐blinded manner")
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding provided ("double‐blinded manner")
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 Unclear risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear