Effect of Ciprofol Injection on Postoperative Cognitive Function

Phase 4Active Not RecruitingNCT07673978

The Second Affiliated Hospital of Chongqing Medical University298 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

298

Conditions

Postoperative Cognitive Dysfunction

Interventions

Ciprofol group

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ² 2. Patients who plan to undergo gastroscopy or colonoscopy in our hospital 3. The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function 4. dextromanuality 5. Voluntarily participate in this study and sign the informed consent form Exclusion Criteria: 1. Pregnant or lactating women 2. Patients who have had cardiovascular and cerebrovascular accidents in the past 3. Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system 4. Patients with obstructive sleep apnea syndrome 5. Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development 6. Patients allergic to ciprofol or propofol drugs 7. Patients with braking, visual/auditory impairments 8. Patients with psychotropic drug addiction or alcohol dependence 9. Patients who themselves or their attending physicians refused to participate in the study

Outcomes

Primary Outcomes

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

Intraoperative and postoperative adverse events

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

Blood Pressure (mmHg)

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

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)

Heart Rate (beats/min)

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

Respiratory Rate (breaths/min)

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

Oxygen Saturation (Pulse Oximetry)

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