| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, dose‐finding study, monoprophylaxis |
| Participants |
Baseline characteristics
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 133 Received treatment (n): 133 Analysed (n): 133 Age (mean ± SD, median (IQR), median (range)): 48.5 (25 to 83) Weight (mean ± SD, median (IQR), median (range)): 65.2 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 95 Non‐smoker (%): NA History of PONV/motion sickness (%): 32.3/15.8 Type of general anaesthesia: inhalational anaesthesia (volatile agent, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 102 Use of perioperative opioids (if yes, which?): 85.7% of patients received opioid analgesics Type of surgery: gynaecological/gastrointestinal
Granisetron (0.1 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 132 Received treatment (n): 132 Analysed (n): 132 Age (mean ± SD, median (IQR), median (range)): 46.8 (24 to 77) Weight (mean ± SD, median (IQR), median (range)): 66.0 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 96 Non‐smoker (%): NA History of PONV/motion sickness (%): 26.5/12.1 Type of general anaesthesia: inhalational anaesthesia (volatile agent, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 95.4 Use of perioperative opioids (if yes, which?): 84.8% of patients received opioid analgesics Type of surgery: gynaecological/gastrointestinal
Granisetron (1.0 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 134 Received treatment (n): 134 Analysed (n): 134 Age (mean ± SD, median (IQR), median (range)): 48.0 (18 to 88) Weight (mean ± SD, median (IQR), median (range)): 62.5 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 98 Non‐smoker (%): NA History of PONV/motion sickness (%): 17.2/9.7 Type of general anaesthesia: inhalational anaesthesia (volatile agent, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 108 Use of perioperative opioids (if yes, which?): 81.3% of patients received opioid analgesics Type of surgery: gynaecological/gastrointestinal
Granisetron (3.0 mg group)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 128 Received treatment (n): 128 Analysed (n): 128 Age (mean ± SD, median (IQR), median (range)): 46.1 (21 to 79) Weight (mean ± SD, median (IQR), median (range)): 65.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 96 Non‐smoker (%): NA History of PONV/motion sickness (%): 30.5/18.0 Type of general anaesthesia: inhalational anaesthesia (volatile agent, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 100.2 Use of perioperative opioids (if yes, which?): 82.0% of patients received opioid analgesics Type of surgery: gynaecological/gastrointestinal
Included criteria: both sexes; over the legal age of consent; undergoing elective open cholecystectomy, open gynaecological procedure, or vaginal hysterectomy during general anaesthesia.
Excluded criteria: ASA IV or V, body weight ≥ 25% above ideal, breastfeeding or pregnancy, known sensitivity to 5‐HT3 antagonists, already experiencing vomiting or moderate to severe nausea, had taken antiemetic drugs in the 24 hours before surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
| Interventions |
Intervention characteristics
Placebo
Dose: NA Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 39.8% (prochlorperazine, metoclopramide)
Granisetron (0.1 mg group)
Dose: 0.1 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA (prochlorperazine, metoclopramide)
Granisetron (1.0 mg group)
Dose: 1.0 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 24.6% (prochlorperazine, metoclopramide)
Granisetron (3.0 mg group)
Dose: 3.0 mg Time point of administration: 5 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 22.7% (prochlorperazine, metoclopramide)
|
| Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 6 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Denmark, Finland, France, Italy, The Netherlands, South Africa, Switzerland, UK
Setting: NA, multi‐centre (35)
Author's name: K.L. Kong
Institution: City Hospital, Dudley Road, Birmingham, UK
Email: NA
Address: City Hospital, Dudley Road, Birmingham, UK
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: no vomiting |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "computer‐generated randomization schedule" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "on the randomization code"
Quote: "the study was blinded by each syringe being preloaded with the same amount of fluid but a different dose of granisetron (0, 0.1 mg, 1.0 mg or 3.0 mg), depending..." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: no statement |
| 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 |
Quote: "the groups were comparable in the type of surgery performed, anaesthetic agents and technique used, duration of operation and perioperative use of opioid analgesics (table 2)"
Quote: "there were no significant treatment‐by‐factor interactions for age, weight, previous history of PONV–motion sickness, menopausal status, duration of anaesthesia or study country (table 4)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
