NCT07132151

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Sep 2025Nov 2027

First Submitted

Initial submission to the registry

August 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2027

Expected
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 12, 2025

Last Update Submit

August 18, 2025

Conditions

Painless AbortionArtificial Intelligence (AI)Ciprofol

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

  • Duration of colonoscopy

    During procedure

  • Lowest value of blood oxygen saturation

    During procedure

  • Induction and maintenance doses of anesthesia

    During procedure

  • Ciprofol related adverse reactions

    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

EXPERIMENTAL

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

Procedure: General Anesthesia

Interventions

AI Controlled General AnesthesiaPROCEDURE

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

Test group
General AnesthesiaPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

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

Jinjiang, Fujian, China

Location

Shishi Hospital

Quanzhou, Fujian, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

The First Affiliated Hospital of Army Medical University

Chongqing, China

Location

The People's Hospital of Yubei District of Chongqing city

Chongqing, China

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Qingwang Lu

CONTACT

+86 13675930836mxbj-2008@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

August 12, 2025

First Posted

August 20, 2025

Study Start

September 8, 2025

Primary Completion

October 8, 2025

Study Completion (Estimated)

November 8, 2027

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations

CN(8)