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

NCT05518929 | Completed Phase 4

• 1 other identifier: KY2022-155-B
• Study Type: interventional
• Target: 1,090
• Locations: 1 country
• Sites: 5

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

Keywords

Ciprofol; Gastroenterological Endoscope; Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia and severe hypoxia

  hypoxia( 75%≤SpO2≤89% for\<60s);severe hypoxia(SpO2\<75%，or SpO2\<90% for \>60s)

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcomes (6)

• Incidence of hypoxia

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Incidence of severe hypoxia

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Incidence of subclinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Success rate of gastroenteroscopy endoscope

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire.

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (2)

Control group(Propofol group)

ACTIVE COMPARATOR

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

Drug: Propofol

Experimental group(ciprofol group)

EXPERIMENTAL

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

Drug: Ciprofol

Interventions

Ciprofol DRUG

The sedation of gastrointestinal endoscopy with Ciprofol

Experimental group(ciprofol group)

Propofol DRUG

The sedation of gastrointestinal endoscopy with Propofol

Control group(Propofol group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age, ≤18 and ≤80 years, no gender limit
• Undergoing routine gastrointestinal endoscopic diagnosis and treatment
• American Society of Aneshesiologists (ASA) classification I-II
• Body mass index (BMI) ≥ 23kg/m2
• Estimated procedure duration less than 30 min
• Clearly understand and voluntarily participate in the study; provide signed informed consent

You may not qualify if:

• 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
• Intend to undergo tracheal intubation or laryngeal mask
• Patients' SpO2 ≤ 95% after entering the endoscope room;
• Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;
• Body weight \< 40kg
• 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
• Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room
• 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
• 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
• Pregnant or breast-feeding women
• Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
• Participated in other clinical trials as a subject within 3 months
• Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
• 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.
• Patients who the investigator considers inappropriate to participate in this trial

Sponsors & Collaborators

• RenJi Hospital: lead
• Zhejiang Tumor Hospital: collaborator
• Beijing Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Dalian Municipal Friendship Hospital: collaborator

Study Sites (5)

Beijing Hospital

Beijing, Beijing Municipality, 10000, China

Location

Zhejiang Tumor Hospital

Zhejiang, Hangzhou, 310000, China

Location

Dalian Municipal Friendship Hospital

Dalian, Liaoning, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Related Publications (1)

• Zhou R, Dai W, Su Z, Lian Y, Wen P, Zhang L, Kong L, Hua Z, Sun Y, Zhao H, Wang Q, Yu W, Su D. Ciprofol Versus Propofol for the Prevention of Hypoxia During Gastrointestinal Endoscopy Procedures in Overweight Patients: A Multicenter, Randomized, Controlled Trial. Dig Endosc. 2026 Feb;38(2):e70102. doi: 10.1111/den.70102.

  PMID: 41626789 DERIVED

MeSH Terms

Conditions

Stomach Ulcer; Stomach Neoplasms; Overweight; Obesity

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Diansan Su

  Department of Anesthesiology Renji Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Open-label, Propofol-controlled

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 29, 2022
• Study Start: September 8, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 30, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)