Reinforcement Learned Automated Anesthesia Systems During Painless Abortion

NCT ID: NCT07132151

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2027-11-08

Brief Summary

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This study compares the automated anesthesia systems for painless abortion (AAS-PA) with traditional anesthesia in painless abortions. It assesses intraoperative indicators (hypoxemia, injection pain, hypotension, hemodynamics, respiratory depression) and postoperative outcomes (nausea, dizziness, recovery time, satisfaction). The AAS-PA group uses AI-adjusted intravenous ciprofol based on real-time vital signs and sedation depth; the traditional group relies on manual anesthesia. The goal is to verify if AAS-PA safely manages sedation, meets painless standards, reduces adverse events, and improves experience, aiding optimized automated protocols.

Detailed Description

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Conditions

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Painless Abortion Artificial Intelligence (AI) Ciprofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Test group

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

Group Type EXPERIMENTAL

AI Controlled General Anesthesia

Intervention Type PROCEDURE

During painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model.

Control group

In the control group, anesthesia will be induced by experienced anesthesiologists.

Group Type EXPERIMENTAL

General Anesthesia

Intervention Type PROCEDURE

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

Interventions

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AI Controlled General Anesthesia

During painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model.

Intervention Type PROCEDURE

General Anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18-45 years
* ASA status Ⅰ to Ⅱ
* Diagnosed with early intrauterine pregnancy
* Body mass index (BMI) between 18 to 28 kg/m2

Exclusion Criteria

* History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
* Known allergy to opioids or ciprofloxacin components
* Cachexia
* History of substance or alcohol abuse
* ASA class III or higher
* Participation in any other drug clinical trial within the past 3 months
* Long-term use of sedative or analgesic medications
* History of neurological disorders and convulsions
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

Shishi Hospital

UNKNOWN

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Army Medical University

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Yubei District of Chongqing city

UNKNOWN

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)

UNKNOWN

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status

Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)

Jinjiang, Fujian, China

Site Status

Shishi Hospital

Quanzhou, Fujian, China

Site Status

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Site Status

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

The First Affiliated Hospital of Army Medical University

Chongqing, , China

Site Status

The People's Hospital of Yubei District of Chongqing city

Chongqing, , China

Site Status

Countries

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China

Central Contacts

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Qingwang Lu

Role: CONTACT

+86 13675930836

Other Identifiers

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SZUS2025002

Identifier Type: -

Identifier Source: org_study_id

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