Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients (SpO2)

The Incidences Of Hypoxia And Severe Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol Compared With Propofol In Overweight Or Obesity Adults Patients, A Multicenter, Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Gastric Ulcer; Gastrointestinal Polyp
• Intervention / Treatment: Drug: Propofol; Drug: Ciprofol

• Study Type: Interventional
• Enrollment (Actual): 1090
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Beijing Hospital
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310000
      • Zhejiang Tumor Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • Dalian Municipal Friendship Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • The Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group(Propofol group); Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg	Drug: Propofol; The sedation of gastrointestinal endoscopy with Propofol
Experimental: Experimental group(ciprofol group); Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg	Drug: Ciprofol; The sedation of gastrointestinal endoscopy with Ciprofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxia	hypoxia( 75%≤SpO2≤89% for<60s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of severe hypoxia	severe hypoxemia(SpO2<75%，or SpO2<90% for >60s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of subclinical respiratory depression	subclinical respiratory depression（90% ≤SpO2 ≤95% ）	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 complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Proportion of corrective hypoxic measures	Treatment of patients with hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Beijing Hospital; Second Hospital of Shanxi Medical University; Zhejiang Tumor Hospital; Dalian Municipal Friendship Hospital
• Investigators: Study Director: Diansan Su, Department of Anesthesiology Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Ciprofol; Gastroenterological Endoscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Overnutrition; Nutrition Disorders; Body Weight; Intestinal Diseases; Signs and Symptoms, Respiratory; Peptic Ulcer; Duodenal Diseases; Obesity; Overweight; Hypoxia; Stomach Ulcer; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: KY2022-155-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No