NCT07673978

Brief Summary

This study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of postoperative cognitive decline in patients undergoing gastrointestinal endoscopy examination between propofol and coprofol, and to optimize the anesthesia medication regimen for patients undergoing gastrointestinal endoscopy examination.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for phase_4

Timeline
5mo left

Started Jun 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not 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 Progress29%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 9, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment

    From the time the patient was enrolled in the study to 24 hours after the treatment

Secondary Outcomes (5)

  • Intraoperative and postoperative adverse events

    From the time the patient enters the operating room to 24 hours after the treatment

  • Blood Pressure (mmHg)

    From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)

  • Heart Rate (beats/min)

    From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)

  • Respiratory Rate (breaths/min)

    From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)

  • Oxygen Saturation (Pulse Oximetry)

    From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)

Other Outcomes (2)

  • The dosage of propofol/ciprofol used

    The dosage of drugs used during this period from anesthesia induction to the end of anesthesia (perioperative period) (approximately 25 - 60 minutes)

  • The patient's stay time in the PACU(Post-Anesthesia Care Unit)

    up to 24 hours

Study Arms (2)

Experimental group (ciprofol)

EXPERIMENTAL

patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.

Drug: Ciprofol group

Control group (propofol)

ACTIVE COMPARATOR

patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.

Drug: Propofol group

Interventions

patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.

Experimental group (ciprofol)

patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.

Control group (propofol)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ²
  • Patients who plan to undergo gastroscopy or colonoscopy in our hospital
  • The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function
  • dextromanuality
  • Voluntarily participate in this study and sign the informed consent form

You may not qualify if:

  • Pregnant or lactating women
  • Patients who have had cardiovascular and cerebrovascular accidents in the past
  • Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system
  • Patients with obstructive sleep apnea syndrome
  • Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development
  • Patients allergic to ciprofol or propofol drugs
  • Patients with braking, visual/auditory impairments
  • Patients with psychotropic drug addiction or alcohol dependence
  • Patients who themselves or their attending physicians refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Guangyou Duan

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations