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

Gastric Cancer Clinical Trial

— SpO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518929
• Other study ID #: KY2022-155-B
• Status: Completed
• Phase: Phase 4
• Start date: September 8, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: June 2024
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: August 30, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastric Ulcer
• Hypoxia
• Obesity
• Overweight
• Stomach Ulcer

Intervention

Drug:
• Ciprofol
The sedation of gastrointestinal endoscopy with Ciprofol
• Propofol
The sedation of gastrointestinal endoscopy with Propofol

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Dalian Municipal Friendship Hospital	Dalian	Liaoning
China	Renji Hospital	Shanghai	Shanghai
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Zhejiang Tumor Hospital	Zhejiang	Hangzhou

Sponsors (5)

Lead Sponsor	Collaborator
RenJi Hospital	Beijing Hospital, Dalian Municipal Friendship Hospital, Second Hospital of Shanxi Medical University, Zhejiang Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Success rate of gastroenteroscopy endoscope		Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	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
Secondary	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