Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Savant 2016.

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

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 38.0 ± 14.9

  • Weight (mean ± SD, median (IQR), median (range)): 59.2 ± 13.1

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 33

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 150.4

  • Use of perioperative opioids (if yes, which?): pentazocine (0.5 mg/kg) as premedication

  • Type of surgery: oral and maxillofacial surgery


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

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): 30

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 31.8 ± 11.1

  • Weight (mean ± SD, median (IQR), median (range)): 56.0 ± 11.8

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 23

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 166.4

  • Use of perioperative opioids (if yes, which?): pentazocine (0.5 mg/kg) as premedication

  • Type of surgery: oral and maxillofacial surgery


Included criteria: 18 to 70 years of age, weighing more than 40 kg, ASA I or II, scheduled for oral and maxillofacial surgery under general anaesthesia
Excluded criteria: unable or unwilling to give informed consent, documented hypersensitivity to any of the study drugs, history of motion sickness or previous PONV, had taken antiemetic drugs within 24 hours before surgery, history of neurological or renal disease, medically compromised and not considered fit for surgery under general anaesthesia, history of adverse reactions to study drugs
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron + dexamethasone
  • Dose: ondansetron 4 mg, dexamethasone 8 mg

  • Time point of administration: ondansetron before induction, dexamethasone during surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 3.3% (metoclopramide 10 mg)


Granisetron + dexamethasone
  • Dose: granisetron 2 mg, dexamethasone 8 mg

  • Time point of administration: granisetron before induction, dexamethasone during surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 0% (metoclopramide 10 mg)

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


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


Complete response (no PONV) in 24 hours
  • Outcome type: dichotomous outcome


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

Identification Sponsorship source: NA
Country: India
Setting: inpatient, single‐centre
Author's name: Rakshit Vijay Sinai Khandeparke
Institution: Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital, Nagercoil, India
Email: rockdotcom1386@gmail.com
Address: Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital, #71 Trivandrum Highway, Parvathipuram, Nagercoil, Tamil Nadu 629003, India, TEL: +91‐7868096436
Language: English
Duration of study: October 2011 to October 2012
Trial registry number: NA
Study's primary outcome: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomly allocated to the two study drug groups (A and B) and in a double blind manner"
Judgement comment: no further information on sequence generation provided
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
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on whether outcome assessors were blinded
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, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear