| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Dolasetron
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 20 Received treatment (n): NA Analysed (n): 20 Age (mean ± SD, median (IQR), median (range)): 54.6 ± 17.4 Weight (mean ± SD, median (IQR), median (range)): 67.2 ± 9.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 7/8/5/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 110.3 Use of perioperative opioids (if yes, which?): 3 µg/kg fentanyl at induction, 16.3 mg piritramide postoperative Type of surgery: hysterectomy
DHB (droperidol)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 20 Received treatment (n): NA Analysed (n): 20 Age (mean ± SD, median (IQR), median (range)): 52.4 ± 13.3 Weight (mean ± SD, median (IQR), median (range)): 71.7 ± 12.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 5/12/3/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 129.8 Use of perioperative opioids (if yes, which?): 3 µg/kg fentanyl at induction, 14.8 mg piritramide postoperative Type of surgery: hysterectomy
Dolasetron + DHB (droperidol)
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 20 Received treatment (n): NA Analysed (n): 20 Age (mean ± SD, median (IQR), median (range)): 51.8 ± 15.0 Weight (mean ± SD, median (IQR), median (range)): 67.7 ± 11.2 BMI (mean +/‐ SD, median (IQR), median [range]): NA ASA I/II/III/IV (n): 8/9/3/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 107.4 Use of perioperative opioids (if yes, which?): 3 µg/kg fentanyl at induction, 14.2 mg piritramide postoperative Type of surgery: hysterectomy
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 20 Received treatment (n): NA Analysed (n): 20 Age (mean ± SD, median (IQR), median (range)): 50.6 ± 16.7 Weight (mean ± SD, median (IQR), median (range)): 67.1 ± 11.1 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): 8/10/2/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): NA Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 111.2 Use of perioperative opioids (if yes, which?): 3 µg/kg fentanyl at induction, 15.1 mg piritramide postoperative Type of surgery: hysterectomy
Included criteria: female, ASA I to III, scheduled for elective hysterectomy
Excluded criteria: liver disease (glutamate‐oxaloacetate‐transaminase > 40 U/L, glutamate‐pyruvate‐transaminase > 40 U/L), severe renal disease (kreatinine > 2.0 mg/dL), known bowel motility disturbance, history of chemotherapy, fever (> 38°C), known allergy to 5‐HT3‐receptor antagonists or dehydrobenzperidole, extreme obesity (> 110 kg), had taken antiemetics or vomited in the past 24 hours before administration of study drug, history of psychiatric disease (including addictions) and psychosomatic disorder, NPO 6 hours
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
| Interventions |
Intervention characteristics
Dolasetron
Dose: 50 mg Time point of administration: 45 to 60 minutes before induction of anaesthesia Route of administration: PO Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV
DHB (droperidol)
Dose: 2.5 mg DHB + placebo Time point of administration: at induction of anaesthesia Route of administration: IV (DHB), PO (placebo) Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV
Dolasetron + DHB (droperidol)
Dose: dolasetron 50 mg, DHB 2.5 mg Time point of administration: dolasetron 45 to 60 minutes before induction of anaesthesia, DHB at induction of anaesthesia Route of administration: IV (DHB), PO (placebo) Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV
Placebo
Dose: placebo Time point of administration: 45 to 60 minutes before induction of anaesthesia Route of administration: PO Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV
|
| Outcomes |
Vomiting (0 to 4 hours)
Adverse events (general notes in the publication, 4 hours' observation)
|
| Identification |
Sponsorship source: Hoechst Marion Roussel Deutschland provided their product Anemet (Dolasetron); no other financial support
Country: Germany
Setting: inpatient, single‐centre
Author's name: Swen Piper
Institution: Klinik für Anästhesiologie und Operative Intensivmedizin, Klinik für Gynäkologie und Geburtshilfe, Klinikum der Stadt Ludwigshafen
Email: NA
Address: Klinik für Anästhesiologie und Operative Intensivmedizin Klinikum der Stadt Ludwigshafen, Bremserstraße 79, D‐67063 Ludwigshafen a. Rh.
Duration of study: NA
Language: German (2 German reviewers)
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 |
Quote: "um eine randomisierte, prospektive einfach"
Judgement comment: 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 |
High risk |
Judgement comment: single‐blinded study design. Blinding of anaesthesiologists not possible due to study design |
| 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: "Zwischen den vier Gruppen bestanden bezüglich demographischer und perioperativer Daten keine signifikanten Unterschiede (Tab. 1)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
