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

Akkaya 2001.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Granisetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 31.7 ± 9.2

  • Weight (mean ± SD, median (IQR), median (range)): 62.4 ± 15.3

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 53

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 168

  • Use of perioperative opioids (if yes, which?): 8 mg postoperative PCA morphine consumption

  • Type of surgery: mastoidectomy


Granisetron + dexamethasone

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 28.1 ± 7.9

  • Weight (mean ± SD, median (IQR), median (range)): 63.2 ± 13.1

  • 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 (%): 0/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 155

  • Use of perioperative opioids (if yes, which?): 3 mg postoperative PCA morphine consumption

  • Type of surgery: mastoidectomy


Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 30.3 ± 8.7

  • Weight (mean ± SD, median (IQR), median (range)): 64.3 ± 10.2

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 47

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 160

  • Use of perioperative opioids (if yes, which?): 13 mg postoperative PCA morphine consumption

  • Type of surgery: mastoidectomy


Included criteria: ASA I or II, mastoidectomy
Excluded criteria: antiemetics within 24 hours before surgery, history of PONV, reflux, pregnancy, menstruation
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV): no; (history of motion sickness, non‐smoker): unclear; (perioperative opioids): yes
Interventions Intervention characteristics
Granisetron

  • Dose: 3 mg, saline

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): chlorpromazine 12.5 mg IM (13%)


Granisetron + dexamethasone

  • Dose: granisetron 3 mg + dexamethasone 8 mg

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): chlorpromazine 12.5 mg IM (0%)


Placebo

  • Dose: saline

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): chlorpromazine 12.5 mg IM (38%)
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (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


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

  • Outcome type: general notes on side effects
Identification Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Taylan Akkaya
Institution: Ankara Egitim Hastanesi Anesteziyoloji ve Reanimasyon Klinigi
Email: NA
Address: NA
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) Low risk Judgement comment: quote: "computer‐generated random sequence" (translated)
Allocation concealment (selection bias) Unclear risk Judgement comment: quote: "random sequence was generated by an independent investigator" (translation)
Insufficient information on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Judgement comment: quote: "anaesthestists and nurses injecting the study drugs were blinded" (translated)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "outcome assessors were blinded" (translated)
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 High risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV): no; (history of motion sickness, non‐smoker): unclear; (perioperative opioids): yes