Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy

Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion; Other: Eyelash reflex guided endoscope insertionn

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Huizhou, Guangdong, China
      • Huizhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G group; 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	Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion; Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.
Active Comparator: C group; The timing point for gastroscope insertion was determined when the corneal reflex was absent.	Other: Eyelash reflex guided endoscope insertionn; Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough	Incidence of coughing during endoscope insertion and examination	From start of endoscope insertion until completion of gastroscopy
Body movement	Incidence of body movement	From start of endoscope insertion until completion of gastroscopy
Hypotension	Incidence of hypotension	From start of endoscope insertion until completion of gastroscopy
Bradycardia	Incidence of bradycardia	From start of endoscope insertion until completion of gastroscopy
Hypoxemia	Incidence of hypoxemia	From start of endoscope insertion until completion of gastroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopist satisfaction score	Endoscopist satisfaction score	Immediately after completion of gastroscopy
PACU discharge time	Time to discharge from PACU	From admission to PACU until discharge from PACU

Collaborators and Investigators

• Sponsor: Huizhou First People's Hospital
• Investigators: Principal Investigator: Jianhao Zeng, MD, Huizhou First People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Painless gastroscopy, remimazolam, remifentanil
• Other Study ID Numbers: KYLL-2024-023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect participant privacy and due to limited data management resources.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No