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

Moussa 2007.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Granisetron (group I)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 29.50 ± 5.29

  • Weight (mean ± SD, median (IQR), median (range)): 109.45 ± 7.34

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

  • ASA I/II/III/IV (n): 0/NA/NA/0

  • Gender (female in %): 73.33

  • Non‐smoker (%): 80

  • History of PONV/motion sickness (%): 10/13.3

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 124

  • Use of perioperative opioids (if yes, which?): 4 patients received buprenorphine as rescue analgesic

  • Type of surgery: laparoscopic bariatric surgery


Granisetron + droperidol (group II)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 29.42 ± 5.39

  • Weight (mean ± SD, median (IQR), median (range)): 105.14 ± 14.25

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

  • ASA I/II/III/IV (n): 0/NA/NA/0

  • Gender (female in %): 70

  • Non‐smoker (%): 83.3

  • History of PONV/motion sickness (%): 10/13.3

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 125

  • Use of perioperative opioids (if yes, which?): 6 patients received buprenorphine as rescue analgesic

  • Type of surgery: laparoscopic bariatric surgery


Granisetron + dexamethasone (group III)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 28.62 ± 5.66

  • Weight (mean ± SD, median (IQR), median (range)): 107.32 ± 11.35

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

  • ASA I/II/III/IV (n): 0/NA/NA/0

  • Gender (female in %): 73.33

  • Non‐smoker (%): 80

  • History of PONV/motion sickness (%): 6.7/13.3

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 126

  • Use of perioperative opioids (if yes, which?): 5 patients received buprenorphine as rescue analgesic

  • Type of surgery: laparoscopic bariatric surgery


Placebo (group IV)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 30

  • Received treatment (n): NA

  • Analysed (n): 30

  • Age (mean ± SD, median (IQR), median (range)): 30.29 ± 5.09

  • Weight (mean ± SD, median (IQR), median (range)): 106.15 ± 11.33

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

  • ASA I/II/III/IV (n): 0/NA/NA/0

  • Gender (female in %): 66.67

  • Non‐smoker (%): 90

  • History of PONV/motion sickness (%): 6.7/13.3

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 126

  • Use of perioperative opioids (if yes, which?): 6 patients received buprenorphine as rescue analgesic

  • Type of surgery: laparoscopic bariatric surgery


Included criteria: ASA II or III, between 18 and 44 years of age, both sexes, general anaesthesia for laparoscopic bariatric surgery
Excluded criteria: known hypersensitivity or contraindication to study medications, chronic nausea, vomiting, motion sickness or retching experience in the 24 hours before anaesthesia, received an antiemetic drug or drug with antiemetic properties during the 24 hours before anaesthesia, breastfeeding, menstruating, conditions that required long‐term opioid administration, gastrointestinal disease, diabetes mellitus, neuromuscular disease, smoker
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Granisetron (group I)

  • Dose: 1 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 0.2 mg/kg IV


Granisetron + droperidol (group II)

  • Dose: granisetron 1 mg, droperidol 1.25 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 0.2 mg/kg IV


Granisetron + dexamethasone (group III)

  • Dose: granisetron 1 mg, dexamethasone 8 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 0.2 mg/kg IV


Placebo (group IV)

  • Dose: saline

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 0.2 mg/kg IV
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Vomiting (0 to 4 hours)

  • Outcome type: dichotomous outcome


Vomiting (4 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)

  • Outcome type: dichotomous outcome


Subjects with any AE (0 to 24 hours)

  • Outcome type: dichotomous outcome


Extrapyramidal symptoms (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: Saudi Arabia
Setting: inpatient, single‐centre
Author's name: Ashraf Ali Moussa
Institution: Department of Anesthesiology MBC‐22, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
Email: ashrafmoussa91@hotmail.com
Address: Department of Anesthesiology MBC‐22, King Faisal Specialist Hospital and Research Center, P.O. Box: 3354, Riyadh 11211, Saudi Arabia
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using a random number table, to receive one of four treatment regimens"
Quote: "generated by a random number function in a computer spread sheet"
Allocation concealment (selection bias) Unclear risk Quote: "randomized numbers generated by a random number function in a computer spread sheet, resulted in a list of 30 assigned to patients receiving one of each four groups. According to this list, personnel not involved in the study prepared identical 5 ml syringes containing each regimen"
Judgement comment: insufficient information on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "personnel not involved in the study prepared identical 5 ml syringes containing each regimen"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "questioning by trained BSc students unaware about the patient antiemetic regimen or by spontaneous complaint by the patient"
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): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no