Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients

NCT ID: NCT05518929

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1090 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2023-08-30

Brief Summary

Ciprofol is a new general anesthetic, which combine with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in the sedation for gastrointestinal endoscopy, especially for overweight and obese patients. We conduct a Multicenter, Randomized, Open-label, Propofol-controlled Study to Evaluate the incidence of hypoxia and severe hypoxia during Gastroenterological Endoscope sedated with CiProfol in Overweight or Obesity patients.

Conditions

Gastric Ulcer; Gastric Cancer; Gastrointestinal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group(Propofol group)

Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

The sedation of gastrointestinal endoscopy with Propofol

Experimental group(ciprofol group)

Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

The sedation of gastrointestinal endoscopy with Ciprofol

Interventions

Ciprofol

The sedation of gastrointestinal endoscopy with Ciprofol

Intervention Type: DRUG

Propofol

The sedation of gastrointestinal endoscopy with Propofol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age, ≤18 and ≤80 years, no gender limit

2. Undergoing routine gastrointestinal endoscopic diagnosis and treatment

3. American Society of Aneshesiologists (ASA) classification I-II

4. Body mass index (BMI) ≥ 23kg/m2

5. Estimated procedure duration less than 30 min

6. Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion Criteria

1. Need to perform complicated endoscopic techniques for diagnosis and treatment, such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, and oral endoscopic muscle dissection

2. Intend to undergo tracheal intubation or laryngeal mask

3. Patients' SpO2 ≤ 95% after entering the endoscope room;

4. Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;

5. Body weight < 40kg

6. Have serious heart diseases such as severe arrhythmia, heart failure, Adams-Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets

7. Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room

8. Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute respiratory tract infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough

9. There is an uncontrolled disease history with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for participating in the study

10. Pregnant or breast-feeding women

11. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.

12. Participated in other clinical trials as a subject within 3 months

13. Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)

14. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.

15. Patients who the investigator considers inappropriate to participate in this trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Tumor Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

Dalian Municipal Friendship Hospital

UNKNOWN

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diansan Su

Role: STUDY_DIRECTOR

Department of Anesthesiology Renji Hospital

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Zhejiang Tumor Hospital

Zhejiang, Hangzhou, China

Dalian Municipal Friendship Hospital

Dalian, Liaoning, China

Renji Hospital

Shanghai, Shanghai Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Countries

China

Other Identifiers

KY2022-155-B

Identifier Type: -

Identifier Source: org_study_id