Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBoston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status class I-II

Expected operation duration less than 1 hour

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI Controlled General Anesthesia

    Procedure/Surgery

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

  • General Anesthesia (GA)

    Procedure/Surgery

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

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of hypoxemia

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

Time frame
During procedure

Secondary outcomes

1

Area under curve of hypoxemia

The area where SpO2 is below 92%.

Time frame
During procedure
2

Lowest value of blood oxygen saturation

Time frame
During procedure
3

Induction and maintenance doses of anesthesia

Doses are recorded in mg/kg/h. The induction period is defined as the interval from the start of anesthesia to the first BIS value below 60. The maintenance period is defined as the interval from the first BIS value below 60 to the end of the drug infusion.

Time frame
During procedure
4

Induction time

The time interval from the start of drug administration to the first BIS ≤ 1.

Time frame
During procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

Lead sponsor

Zhengzhou Central Hospital

Collaborator

Xinzheng Public People's Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

Anxi County Hospital

Collaborator

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

Collaborator