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Effect of Remimazolam Besylate on Vagal Reflex During Painless Colonoscopy in Older Patients,A Randomized Controlled Study Based on Mixed-Effects Modeling and Event Burden Analysis

Ramelzole benzenesulfonate for eliminating the vagal reflex during painless colonoscopy in elderly patients Impact

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123722
Enrollment
Unknown
Registered
2026-04-29
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

None

Interventions

The remimazolam combined with nalbuphine group (Group N):Slow intravenous injection of 0.1 mg/kg nalbuphine hydrochloride, followed by intravenous injection of 0.2 mg/kg remimazolam besylate
the remimazolam alone group (Group R):Slow intravenous infusion of 0.2 mg/kg of remimazolam succinate
the propofol alone group (Group P):Slow intravenous infusion of 1.5 mg/kg propofol and medium/long chain fat emulsion injection

Sponsors

Zhoushan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent provided by the patient or their legal representative; 2. Normal mental and consciousness status before the procedure; 3. Meeting the indications for painless colonoscopy examination and voluntarily accepting anesthesia for the procedure; 4. Aged 60 to 70 years;

Exclusion criteria

Exclusion criteria: 1. Presence of severe organic diseases involving the heart, liver, lung, kidney, or other major organs; 2. Known allergy to any drug used in the study; 3. Long-term use of analgesic or sedative medications; 4. Cognitive impairment or inability to cooperate with the study procedures; 5. Refusal or inability to provide informed consent;

Design outcomes

Primary

MeasureTime frame
The incidence rate of vagus nerve reflexes;

Secondary

MeasureTime frame
Hemodynamic indicators: including heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure;Effectiveness indicators: include the onset time of sedation and the recovery time from anesthesia.;Safety indicators: Incidence of adverse reactions during the perioperative period;

Countries

China

Contacts

Public ContactBo Liu

Zhoushan Hospital

3355145251@qq.com+86 188 4617 8423

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026