| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 5 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Placebo (group A)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 29.50 ± 5.29 Weight (mean ± SD, median (IQR), median (range)): 75.14 ± 14.25 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 86.7 History of PONV/motion sickness (%): 10.0/10.0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 51.44 Use of perioperative opioids (if yes, which?): 0.5 mg/kg meperidine IV (PACU), 1 mg/kg meperidine IV (every 6 hours) Type of surgery: caesarean section
Granisetron + dexamethasone (group B)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 29.42 ± 5.39 Weight (mean ± SD, median (IQR), median (range)): 77.32 ± 11.35 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 93.3 History of PONV/motion sickness (%): 6.7/10.0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 49.73 Use of perioperative opioids (if yes, which?): 0.5 mg/kg meperidine IV (PACU), 1 mg/kg meperidine IV (every 6 hours) Type of surgery: caesarean section
Granisetron + droperidol (group C)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 28.62 ± 5.66 Weight (mean ± SD, median (IQR), median (range)): 79.45 ± 7.34 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 90.0 History of PONV/motion sickness (%): 6.7/10.0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 53.88 Use of perioperative opioids (if yes, which?): 0.5 mg/kg meperidine IV (PACU), 1 mg/kg meperidine IV (every 6 hours) Type of surgery: caesarean section
Droperidol (group D)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 30.29 ± 5.09 Weight (mean ± SD, median (IQR), median (range)): 77.30 ± 9.90 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 83.3 History of PONV/motion sickness (%): 10.0/13.3 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 50.88 Use of perioperative opioids (if yes, which?): 0.5 mg/kg meperidine IV (PACU), 1 mg/kg meperidine IV (every 6 hours) Type of surgery: caesarean section
Granisetron (group E)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 28.96 ± 5.95 Weight (mean ± SD, median (IQR), median (range)): 74.15 ± 11.33 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): 86.7 History of PONV/motion sickness (%): 10.0/13.3 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 49.29 Use of perioperative opioids (if yes, which?): 0.5 mg/kg meperidine IV (PACU), 1 mg/kg meperidine IV (every 6 hours) Type of surgery: caesarean section
Included criteria: ASA I or II, scheduled for caesarean section
Excluded criteria: underlying pro‐emetic disease and/or taking antiemetic drugs
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
Placebo (group A)
Dose: 5 mL saline Time point of administration: immediately after clamping of the umbilical cord Route of administration: IV Rescue antiemetics (if yes, which?): 26.7% (metoclopramide 10 mg IV)
Granisetron + dexamethasone (group B)
Dose: granisetron 40 µg/kg, dexamethasone 8 mg Time point of administration: immediately after clamping of the umbilical cord Route of administration: IV Rescue antiemetics (if yes, which?): 0.0% (metoclopramide 10 mg IV)
Granisetron + droperidol (group C)
Dose: granisetron 40 µg/kg, droperidol 1.25 mg Time point of administration: immediately after clamping of the umbilical cord Route of administration: IV Rescue antiemetics (if yes, which?): 3.3% (metoclopramide 10 mg IV)
Droperidol (group D)
Dose: 1.25 mg Time point of administration: immediately after clamping of the umbilical cord Route of administration: IV Rescue antiemetics (if yes, which?): 16.7% (metoclopramide 10 mg IV)
Granisetron (group E)
Dose: 40 µg/kg Time point of administration: immediately after clamping of the umbilical cord Route of administration: IV Rescue antiemetics (if yes, which?): 3.3% (metoclopramide 10 mg IV)
|
| Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 3 hours)
Vomiting (3 to 24 hours)
PONV (0 to 24 hours)
Subjects with any SAE (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: departmental sources
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Ismail Serhat Kocamanoglu
Institution: Department of Anesthesiology, Onkoduz Mayis University, Samsun, Turkey
Email: serhatk@omu.edu.tr
Address: Department of Anesthesiology, Onkoduz Mayis University, Samsun, Turkey
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) |
Unclear risk |
Judgement comment: quote: "prospectively and randomly assigned to one of five groups". 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 |
Low risk |
Judgement comment: quote: "total volume of antiemetic solutions were 5 ml with the saline added, and thus maintaining the anesthesiologist blinding to the study drug" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Judgement comment: quote: "one of the investigators, who were blinded to the treatment group, recorded all the variables observed" |
| 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 |
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 |
