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NCT Number: NCT06857344

Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy

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.

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Key information

Conditions

Anesthesia Induction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxi County Hospital, Anxi, Fujian, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI Controlled General Anesthesia

Procedure

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

General Anesthesia (GA)

Procedure

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

Primary outcomes

  1. Incidence of hypoxemia

    Time frame: During procedure

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

Secondary outcomes

  1. Area under curve of hypoxemia

    Time frame: During procedure

    The area where SpO2 is below 92%.

  2. Lowest value of blood oxygen saturation

    Time frame: During procedure

  3. Induction and maintenance doses of anesthesia

    Time frame: During procedure

    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.

  4. Induction time

    Time frame: During procedure

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

  5. Complete recovery time

    Time frame: During procedure

    Time interval from cessation of anesthetic agents to BIS > 80.

  6. Incidence of hypotension

    Time frame: During procedure

    systolic blood pressure < 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes

  7. Counts of body movement

    Time frame: During procedure

  8. Dose of norepinephrine

    Time frame: During procedure

  9. Duration of colonoscopy

    Time frame: During procedure

  10. Ciprofol related adverse reactions

    Time frame: During procedure

    Included sinus bradycardia, dizziness

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Chu

CONTACT

[email protected]

+86 138 3810 0696

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Anxi County Hospital
  • Henan Provincial People's Hospital
  • Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
  • Xinzheng Public People's Hospital
  • Zhengzhou Central Hospital

Registry information

Official study title

Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy

Acronym: AAS-GE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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