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Active, Not Recruiting

NCT Number: NCT07673978

Effect of Ciprofol Injection on Postoperative Cognitive Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ciprofol group

Drug

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

Propofol group

Drug

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

Primary outcomes

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

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

Secondary outcomes

  1. Intraoperative and postoperative adverse events

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

  2. Blood Pressure (mmHg)

    Time frame: 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)

    Non-invasive BP measured by cuff after entry and intermittently during surgery. Hypotension: SBP decrease >30% from baseline; Hypertension: SBP increase >30% from baseline.

  3. Heart Rate (beats/min)

    Time frame: 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)

    Read from monitor. Bradycardia: <50 bpm or decrease ≥25% from baseline; Tachycardia: >100 bpm or increase ≥25% from baseline.

  4. Respiratory Rate (breaths/min)

    Time frame: 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)

    Read from monitor or counted over 1 min. Respiratory depression: <8 breaths/min lasting >30 sec.

  5. Oxygen Saturation (Pulse Oximetry)

    Time frame: 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)

    Read from monitor. Hypoxemia: SpO2 <90% lasting >15 sec.

Other outcomes

  1. The dosage of propofol/ciprofol used

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

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

    Time frame: up to 24 hours

    The period from when the patients enter the PACU until they leave the PACU

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

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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