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

Dua 2014.

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): 50

  • Received treatment (n): NA

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 34.26 ± 13.77

  • Weight (mean ± SD, median (IQR), median (range)): 60.22 ±‐ 6.876

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

  • ASA I/II/III/IV (n): 36/14

  • Gender (female in %): 48

  • Non‐smoker (%): 100

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 179.44

  • Use of perioperative opioids (if yes, which?): 121.3

  • Type of surgery: tympanoplasty and mastoidectomy


Granisetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 32.48 ± 14.56

  • Weight (mean ± SD, median (IQR), median (range)): 60.66 ± 7.847

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

  • ASA I/II/III/IV (n): 39/11

  • Gender (female in %): 38

  • Non‐smoker (%): 100

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 179.5

  • Use of perioperative opioids (if yes, which?): 109.8 µg intraoperative fentanyl

  • Type of surgery: tympanoplasty and mastoidectomy


Included criteria: ASA I or II, 18 to 65 years of age, undergoing middle ear surgery (tympanoplasty and mastoidectomy) under general anaesthesia
Excluded criteria: history of smoking, gastritis, heartburn, motion sickness; previous PONV; lower oesophageal sphincter disorders; Ellison‐Zollinger syndrome; uncontrolled hypertension; poorly controlled diabetes; preoperative emesis < 6 hours before surgery
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
Ondansetron

  • Dose: 8 mg

  • Time point of administration: 30 minutes before reversal of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): ondansetron 8 mg IV


Granisetron

  • Dose: 1 mg

  • Time point of administration: 30 minutes before reversal of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): ondansetron 8 mg IV
Outcomes Vomiting (0 to 24 hours, PONV score 2 +3)

  • Outcome type: dichotomous outcome


Vomiting (6 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours, PONV score 1)

  • Outcome type: dichotomous outcome


Subjects with any AE (0 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (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: India
Setting: inpatient, single‐centre
Author's name: Naresh Dua
Institution: Department of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, India
Email: ndua14@yahoo.com
Address: Department of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi 110060, India
Duration of study: NA
Language: English
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 Quote: "randomization list was prepared by a random number function in a computer spreadsheet"
Allocation concealment (selection bias) Unclear risk Quote: "a randomization list was prepared by a random number function in a computer spreadsheet and identical syringes containing each drug were prepared by personnel not involved in this study"
Judgement comment: insufficient information on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "a randomization list was prepared by a random number function in a computer spreadsheet and identical syringes containing each drug were prepared by personnel not involved in this study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "by direct questioning by the attending anaesthesiologist without knowledge of which antiemetic the patient had received"
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: "there were no significant differences between the groups with regard to age, sex, weight, height, sex, ASA physical status, duration of anaesthesia and surgery, type of surgery (tympanoplasty, mastoidectomy), preoperative PONV, intraoperative analgesic requirements, and time to first feeding"
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