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Comparison of remazolam-based and propofol-based total intravenous anesthesia on recovery quality in endoscopic mucosal dissection (ESD): a randomized controlled study

Comparison of remazolam-based and propofol-based total intravenous anesthesia on recovery quality in endoscopic mucosal dissection (ESD): a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110414
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Postoperative recovery quality

Interventions

Remazolam group (Group R):During anesthesia induction, remimazolam is administered intravenously at a dose of 0.2-0.3 mg/kg
for anesthesia maintenance, remimazolam is infused intravenously via a pump at a rate of 1.0-2.0 mg/kg/h.
Propofol group (Group P):During anesthesia induction, propofol is administered intravenously at a dose of 1.5-2.0 mg/kg
for anesthesia maintenance, propofol is infused intravenously via a pump at a rate of 4.0-10.0 mg/kg/h.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily participate in this study and sign an informed consent form; 2.Age 18-65 years old, gender unrestricted, body mass index (BMI) 18-30 kg/m^2; 3.ASA I-III grade; 4.Intending to undergo endoscopic upper gastrointestinal mucosal resection procedures (e.g., esophageal ESD, gastric ESD, etc.), with an estimated operation time >=30 minutes.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1. Pregnant or breastfeeding women, or those planning pregnancy within three months; 2. Contraindications or hypersensitivity to benzodiazepines, propofol, opioids, or their components; 3. Preoperative respiratory/circulatory dysfunction (e.g., acute upper respiratory infection, asthma exacerbation, acute exacerbation of chronic obstructive pulmonary disease, respiratory failure, uncontrolled severe hypertension, heart failure); 4. Severe hepatic impairment (Child-Pugh Class C) or severe renal failure (requiring dialysis); 5. History of mental illness, cognitive impairment, or inability to complete questionnaire assessment; 6. Long-term use of sedatives, anti-anxiety medications, or opioid analgesics; 7. Participation in other clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
Quality of recovery-15 (QoR-15) score on postoperative day 1;

Secondary

MeasureTime frame
Quality of recovery-15 (QoR-15) scores on postoperative day 3 and Postoperative day 7;Incidence of hypotension;Sleep status on postoperative day 1, day 3, and day 7;Anxiety and depression scores on postoperative day 1, day 3, and day 7;Pain score and severity within 24 hours postoperatively;Incidence and severity of PONV within 24 hours postoperatively;The severity of cough during the awakening period;Satisfaction scores of endoscopists and patients regarding the surgical experience;Incidence of perioperative adverse events;Total Perioperative Dose of Anesthetic and Vasoactive Agents;

Countries

China

Contacts

Public ContactXing Na

The First Affiliated Hospital of Zhengzhou University

fccxingn@zzu.edu.cn+86 139 4909 5172

Outcome results

None listed

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