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Effect of Remimazolam versus Propofol on the Quality of Recovery After Colonoscopy: a Randomized Controlled Trial

Effect of Remimazolam versus Propofol on the Quality of Recovery After Colonoscopy: a Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041568
Enrollment
Unknown
Registered
2020-12-29
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Interventions

R group:Give the initial dose of 5.0 mg of remimazolam. If sufficient sedation is not obtained, inject supplementary doses of remimazolam (2.5 mg per dose), and the supplement interval must be more th
P group:Give the initial dose of 1.5 mg/kg of propofol. If sufficient sedation is not obtained, inject supplementary doses of propofol (0.5mg/kg per dose), and the supplement interval must be more tha

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Scheduled to undergo a colonoscopy; 2.Aged 18~60 years; 3.American Society of Anesthesiologists (ASA) physical status classification system risk class I~II; 4.Body mass index (BMI)< 35 kg/m2; 5.Patient was voluntary to participate in the trial and signed the informed consents, and willing to comply with study requirements.

Exclusion criteria

Exclusion criteria: 1.About to receive endotracheal intubation or laryngeal mask; 2.Required complex endoscope procedures (such as endoscopic submucosal dissection, transoral endoscopic myotomy, etc.); 3.Patients with psychiatric disorders (schizophrenia, mania, bipolar disorder, mental disorder, etc.), a long history of use of psychotropic drugs, and cognitive dysfunction. 4.History of drug abuse, and alcohol abuse within the 2 years before screening stage (alcohol abuse: average daily consumption of more than 2 single units of alcohol (1 unit =360 mL beer or 45 mL 40% liquor or 150 mL wine)); 5.Use of benzodiazepines and/or opioids for nearly three months; 6.Allergy or contraindication to benzodiazepines, opioids, propofol and their components; 7.Unable to understand the scale of recovery quality, and difficult to complete the survey of recovery quality.

Design outcomes

Primary

MeasureTime frame
postoperative quality of recovery scale;incidence of adverse events (hypotension, respiratory depression, pain at the injection site);Patient satisfaction;Endoscopic doctor satisfaction;Anesthesia induction time;awake time;

Secondary

MeasureTime frame
postoperative quality of recovery scale;sedation success rate;

Countries

China

Contacts

Public ContactDunyi Qi

Xuzhou Medical University

9472540@qq.com+86 15162159886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026