Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy

NCT07471893 | Completed

• 1 other identifier: KYLL-2024-023-01
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Painless gastroscopy, remimazolam, remifentanil

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Endoscopist satisfaction score

  Immediately after completion of gastroscopy

• PACU discharge time

  From admission to PACU until discharge from PACU

Study Arms (2)

G group

EXPERIMENTAL

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

C group

ACTIVE COMPARATOR

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

Other: Eyelash reflex guided endoscope insertionn

Interventions

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

Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.

G group

Eyelash reflex guided endoscope insertionn OTHER

Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.

C group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Huizhou First Hospital: lead

Study Sites (1)

Huizhou First People's Hospital

Huizhou, Guangdong, China

Location

Study Officials

• Jianhao Zeng, MD

  Huizhou First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, anesthesiologists performing the procedure, and outcome assessors are blinded to group allocation.Group assignment is concealed using a random number table or central randomization system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Model Details: A randomized, parallel-group, controlled clinical study. Eligible patients will be randomly assigned to two or more groups to compare different timing criteria for endoscope insertion during painless gastroscopy.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: May 8, 2024
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)