Rho 2001‐2.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
|
Participants |
Baseline characteristics Control (group 2)
Droperidol (group 4)
Included criteria: healthy female patients 20 to 60 years of age, scheduled to undergo laparoscopic hysterectomy and ovarian tumour removal, ASA I or II Excluded criteria: history of recurrent respiratory disease, endocrine system/nervous system disease, pregnancy, obesity (> 50% of normal body weight) Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear; (duration of anaesthesia): yes |
|
Interventions |
Intervention characteristics Control (group 2)
Droperidol (group 4)
|
|
Outcomes |
Vomiting (3 to 6 hours)
PONV (0 to 24 hours)
Complete response (no PONV) in 24 hours
Headache (0 to 48 hours)
Sedation/drowsiness (at recovery room, during 30 minutes postoperative, 30 minutes to 1 hour, 1 to 3 hours, 3 to 6 hours, 6 to 24 hours)
Adverse events (general notes in the publication, 48 hours' observation)
|
|
Identification |
Sponsorship source: NA Country: Korea Setting: inpatient, single‐centre Author's name: Shi Youn Rho Institution: Department of Anesthesiology, Chungnam National University Hospital, Daejeon, Korea Email: NA Address: NA Duration of study: April 2000 to July 2000 Language: Korean (Google Translator) Study's primary outcome: NA Trial registry number: NA |
|
Notes | Study with 4 groups split into 2 sub‐studies (Rho 2005‐1, Rho 2005‐2), with 2 groups each due to different anaesthesia regimens (TIVA vs inhalational) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: quote: "randomly assigned". 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: no statement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: quote: "observed by a familiar nurse who was trained for this study" (translated). No information on blinding of outcome assessors provided |
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 | High risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear; (duration of anaesthesia): yes |