NCT06857344

Brief Summary

The goal of this clinical trial is to compare the performance difference between trained model and clinical professionals in anesthesia control during gastrointestinal endoscopy. The participants would include adults aged between 18-65 years old with ASA scores I-II. The main questions it aims to answer are:

  • Can AI model successfully and safely perform anesthesia during gastrointestinal endoscopy?
  • Researchers hypothesis that anesthesia performed by professionals is not inferior to those performed by AI model. The researchers will compare the results of the AI group with the traditional group to see if both groups have similar success rates in performing anesthesia. Participants will fast for 8 hours before the procedure, and drinking water will be prohibited for 2 hours after taking the intestinal purgatives.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

February 26, 2025

Last Update Submit

August 12, 2025

Conditions

Anesthesia Induction

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoxemia

    Hypoxemia is defined as blood oxygen saturation below 92% at any time.

    During procedure

Secondary Outcomes (10)

  • Area under curve of hypoxemia

    During procedure

  • Lowest value of blood oxygen saturation

    During procedure

  • Induction and maintenance doses of anesthesia

    During procedure

  • Induction time

    During procedure

  • Complete recovery time

    During procedure

  • +5 more secondary outcomes

Study Arms (2)

Test group

EXPERIMENTAL

In the test group, participants will receive anesthesia via an AI model.

Procedure: AI Controlled General Anesthesia

Control group

ACTIVE COMPARATOR

In the control group, anesthesia will be induce by experienced anesthesiologists

Procedure: General Anesthesia (GA)

Interventions

AI Controlled General AnesthesiaPROCEDURE

During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.

Test group
General Anesthesia (GA)PROCEDURE

Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status class I-II
  • Expected operation duration less than 1 hour

You may not qualify if:

  • History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
  • Known allergy to opioids or ciprofloxacin components
  • Cachexia
  • Hypothermia; history of narcotic abuse; chronic alcoholism; obesity (BMI \>30); patients with apnea
  • Current pregnancy or lactation
  • History of substance abuse or alcohol dependence
  • Participation in any other drug clinical trial within the past 3 months
  • Obesity (BMI \>30 kg/m²)
  • Procedure termination due to gastric retention or inadequate bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Anxi County Hospital

Anxi, Fujian, China

RECRUITING

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus

Jinjiang, Fujian, China

RECRUITING

Xinzheng Public People's Hospital

Xinzheng, Henan, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Dr. Chu

CONTACT

+86 138 3810 0696jimmynetchu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 4, 2025

Study Start

May 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

CN(5)