Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-05-03 @ 2:35 PM
Study NCT ID:
NCT07471893
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy
Sponsor:
Huizhou First Hospital
Organization:
Study Overview
Official Title:
Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: