| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 35 Age (mean ± SD, median (IQR), median (range)): 68 (58 to 74) Weight (mean ± SD, median (IQR), median (range)): 70 (63 to 80) BMI (mean ± SD, median (IQR), median (range)): 26.2 (23.7 to 29.2) ASA I/II/III/IV (n): 3/19/13/0 Gender (female in %): 70.9 Non‐smoker (%): 74.3 History of PONV/motion sickness (%): 22.9/22.9 Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.5 mg to 1 mg alfentanil, 1 patient received piritramide Type of surgery: cataract surgery
Droperidol
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 35 Age (mean ± SD, median (IQR), median (range)): 70 (60 to 76) Weight (mean ± SD, median (IQR), median (range)): 71 (64 to 81) BMI (mean ± SD, median (IQR), median (range)): 26.0 (24.0 to 29.1) ASA I/II/III/IV (n): 5/14/16/0 Gender (female in %): 70.9 Non‐smoker (%): 88.6 History of PONV/motion sickness (%): 22.9/17.1 Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.5 mg to 1 mg alfentanil, 1 patient received piritramide Type of surgery: cataract surgery
Dolasetron
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 36 Age (mean ± SD, median (IQR), median (range)): 68 (58 to 74) Weight (mean ± SD, median (IQR), median (range)): 71 (64 to 78) BMI (mean ± SD, median (IQR), median (range)): 25.7 (23.4 to 27.7) ASA I/II/III/IV (n): 11/14/11/0 Gender (female in %): 69.4 Non‐smoker (%): 83.3 History of PONV/motion sickness (%): 25.0/25.0 Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.5 mg to 1 mg alfentanil, 1 patient received piritramide Type of surgery: cataract surgery
Droperidol + dolasetron
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): NA Received treatment (n): NA Analysed (n): 35 Age (mean ± SD, median (IQR), median (range)): 70 (56 to 60) Weight (mean ± SD, median (IQR), median (range)): 69 (60 to 84) BMI (mean ± SD, median (IQR), median (range)): 25.5 (23.9 to 29.5) ASA I/II/III/IV (n): 7/23/5/0 Gender (female in %): 70.9 Non‐smoker (%): 91.4 History of PONV/motion sickness (%): 20.0/14.3 Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA Use of perioperative opioids (if yes, which?): 0.5 mg to 1 mg alfentanil, 1 patient received piritramide Type of surgery: cataract surgery
Included criteria: scheduled for cataract surgery under general anaesthesia
Excluded criteria: ASA III or IV, senile dementia, psychiatric disease, cerebral circulation disturbances, received antiemetics during the last 2 weeks, adipositas (BMI > 35 kg/m²), intolerance to or contraindications against 1 of the study medications (e.g. M. Parkinson)
Pretreatment: baseline characteristics (age, weight): no; (ASA): yes. Potential effect modifiers (gender, non‐smoker, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia): unclear |
| Interventions |
Intervention characteristics
Placebo
Dose: NaCl Time point of administration: 5 to 10 minutes before end of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 20.0% (10 mg metoclopramide or 0.5 mg/kg dimenhydrinate)
Droperidol
Dose: 10 µg/kg Time point of administration: 5 to 10 minutes before end of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 5.7% (10 mg metoclopramide or 0.5 mg/kg dimenhydrinate)
Dolasetron
Dose: 12.5 mg/kg Time point of administration: 5 to 10 minutes before end of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 5.6% (10 mg metoclopramide or 0.5 mg/kg dimenhydrinate)
Droperidol + dolasetron
Dose: droperidol 10 µg/kg, dolasetron 12.5 mg Time point of administration: 5 to 10 minutes before end of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): 5.7% (10 mg metoclopramide or 0.5 mg/kg dimenhydrinate)
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Extrapyramidal symptoms, restlessness (0 to 24 hours)
Headache (examination room)
Sedation/drowsiness (at 2 hours, 5 hours, 8 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
| Identification |
Sponsorship source: NA
Country: Germany
Setting: inpatient, single‐centre
Author's name: Leopold Eberhart
Institution: Klinik für Anästhesiologie Universität Ulm
Email: leopold.eberhart@medizin.uni‐ulm.de
Address: Klinik für Anästhesiologie Universität Ulm, Steinhövelstraße 9; 89075 Ulm
Duration of study: NA
Language: German
Study's primary outcome: complete response in 24 hours
Trial registry number: NA |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "eines computergenerierten Randomisierungsplans"
Judgement comment: quote (translated): "computer‐generated randomization" |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "droperidol in 10 ml NaCl. Die Studienmedikation wurde von einem Mitarbeiter vorbereitet, der nicht in die Studie involviert war. Am Abend vor, und am"
Judgement comment: quote (translated): "the study medication was prepared by an employee who was not involved in the study" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: no statement |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "insgesamt konnten die Daten von sieben Patienten nicht ausgewertet werden. Die Gründe dafür waren: Absage oder Terminverschiebung der Operation (n = 5) oder die Nichteinhaltung des vorgesehenen Narkoseverfahrens (n = 2)"
Judgement comment: missing outcome data were described and were unrelated to outcomes of interest |
| Selective reporting (reporting bias) |
Unclear risk |
Judgement comment: no reference to a study protocol or trial registry number reported |
| Other bias |
High risk |
Judgement comment: baseline characteristics (age, weight): no; (ASA): yes. Potential effect modifiers (gender, non‐smoker, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia): unclear |
