Clinical trial NCT06857344: Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy
Official title: Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia Induction
Lead sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zhengzhou Central Hospital
First posted: 2025-03-04
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: During procedure
Secondary outcomes:
measure: Area under curve of hypoxemia
timeFrame: During procedure
measure: Lowest value of blood oxygen saturation
timeFrame: During procedure
measure: Induction and maintenance doses of anesthesia
timeFrame: During procedure
measure: Induction time
timeFrame: During procedure
measure: Complete recovery time
timeFrame: During procedure
measure: Incidence of hypotension
timeFrame: During procedure
measure: Counts of body movement
timeFrame: During procedure
measure: Dose of norepinephrine
timeFrame: During procedure
measure: Duration of colonoscopy
timeFrame: During procedure
measure: Ciprofol related adverse reactions
timeFrame: During procedure
Other outcomes:
Locations:
city: Anxi
country: China
facility: Anxi County Hospital
state: Fujian
city: Jinjiang
country: China
facility: Jinjiang Hospital
state: Fujian
city: Xinzheng
country: China
facility: Xinzheng Public People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
Study officials:
References: