| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 7 groups, monoprophylaxis, dose‐finding study |
| Participants |
Baseline characteristics
L‐sulpiride (group A)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 30.1 ± 1.1 Weight (mean ± SD, median (IQR), median (range)): 54.3 ± 4.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
L‐sulpiride (group B)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 27.0 ± 1.5 Weight (mean ± SD, median (IQR), median (range)): 48.2 ± 2.5 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Droperidol (group C)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 27.5 ± 2.7 Weight (mean ± SD, median (IQR), median (range)): 47.4 ± 1.8 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Droperidol (group D)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 26.4 ± 2.1 Weight (mean ± SD, median (IQR), median (range)): 52.3 ± 4.3 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Metoclopramide (group E)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 29.2 ± 1.8 Weight (mean ± SD, median (IQR), median (range)): 55.2 ± 3.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Metoclopramide (group F)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 28.6 ± 1.4 Weight (mean ± SD, median (IQR), median (range)): 55.1 ± 4.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Placebo (group G)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 50 Received treatment (n): NA Analysed (n): 50 Age (mean ± SD, median (IQR), median (range)): 29.1 ± 2.2 Weight (mean ± SD, median (IQR), median (range)): 51.3 ± 2.7 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (N₂O, thiopentone) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): fentanyl 0.05 mg for premedication Type of surgery: diagnostic curettage or spontaneous or voluntary abortion
Included criteria: ASA class I or II, undergoing diagnostic curettage or spontaneous or voluntary abortion
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
| Interventions |
Intervention characteristics
L‐sulpiride(group A)
Dose: 50 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
L‐sulpiride (group B)
Dose: 100 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Droperidol (group C)
Dose: 2.5 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Droperidol (group D)
Dose: 5.0 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Metoclopramide (group E)
Dose: 10 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Metoclopramide (group F)
Dose: 20 mg Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Placebo (group G)
Dose: saline Time point of administration: 15 minutes before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Vomiting (0 to 3 hours)
Headache (time point unknown)
Sedation/drowsiness (time point unknown)
Visual disturbances (e.g. blurred vision) (time point unknown)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Italy
Setting: single‐centre
Author's name: Angelo Forgione
Institution: Department of Research Development, RAZIZZA S.P.A.
Email: NA
Address: Ravizza S.P.A., Via Europa 35, 20053 Muggio (Milan) Italy
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) |
Unclear risk |
Judgement comment: quote: "were randomly given". 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 ("double‐blind fashion") |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: insufficient information on blinding ("double‐blind fashion") |
| 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): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
