Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy

Huizhou First People's Hospital

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Eyelash reflex guided endoscope insertionn; Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT07471893

KYLL-2024-023-01

Details and patient eligibility

About

This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.

Full description

This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.

Enrollment: 342 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy

Exclusion criteria

• (1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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342 participants in 2 patient groups

G group

Experimental group

Description:

The timing point for gastroscope insertion was defined as when the patient's mandible was lifted, no motor response was observed any longer, and the h

Treatment:

Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion

C group

Active Comparator group

Description:

The timing point for gastroscope insertion was determined when the corneal reflex was absent.

Treatment:

Other: Eyelash reflex guided endoscope insertionn