Back to results

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

Primary Purpose

Gastric Ulcer, Gastric Cancer, Gastrointestinal Polyp

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ciprofol

Propofol

About this trial

This is an interventional treatment trial for Gastric Ulcer focused on measuring Ciprofol, Gastroenterological Endoscope, Overweight, Obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Beijing HospitalRecruiting
Zhejiang Tumor HospitalRecruiting
Dalian Municipal Friendship HospitalRecruiting
Renji HospitalRecruiting
The Second Hospital of Shanxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group(Propofol group)

Experimental group(ciprofol group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of hypoxia and severe hypoxia

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

Secondary Outcome Measures

Incidence of hypoxia

hypoxia( 75%≤SpO2≤89% for<60s)

Incidence of severe hypoxia

severe hypoxemia(SpO2<75%，or SpO2<90% for >60s)

Incidence of subclinical respiratory depression

subclinical respiratory depression（90% ≤SpO2 ≤95% ）

Success rate of gastroenteroscopy endoscope

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.

Proportion of corrective hypoxic measures

Treatment of patients with hypoxia

Full Information

NCT ID

NCT05518929

First Posted

August 24, 2022

Last Updated

September 22, 2023

Sponsor

RenJi Hospital

Collaborators

Zhejiang Tumor Hospital, Beijing Hospital, Second Hospital of Shanxi Medical University, Dalian Municipal Friendship Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05518929

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

Collaborators

Zhejiang Tumor Hospital, Beijing Hospital, Second Hospital of Shanxi Medical University, Dalian Municipal Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Ulcer, Gastric Cancer, Gastrointestinal Polyp

Keywords

Ciprofol, Gastroenterological Endoscope, Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, Randomized, Open-label, Propofol-controlled

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group(Propofol group)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Experimental group(ciprofol group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ciprofol

Intervention Description

The sedation of gastrointestinal endoscopy with Ciprofol

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

The sedation of gastrointestinal endoscopy with Propofol

Primary Outcome Measure Information:

Title

Incidence of hypoxia and severe hypoxia

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Incidence of hypoxia

Description

hypoxia( 75%≤SpO2≤89% for<60s)

Time Frame

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

Title

Incidence of severe hypoxia

Description

severe hypoxemia(SpO2<75%，or SpO2<90% for >60s)

Time Frame

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

Title

Incidence of subclinical respiratory depression

Description

subclinical respiratory depression（90% ≤SpO2 ≤95% ）

Time Frame

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

Title

Success rate of gastroenteroscopy endoscope

Time Frame

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

Title

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

Description

Patients complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness.

Time Frame

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

Title

Proportion of corrective hypoxic measures

Description

Treatment of patients with hypoxia

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

weifeng Yu, PhD

Phone

13901961704

ywf808@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

diansan Su, PhD

Phone

18616514088

diansansu@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diansan Su

Organizational Affiliation

Department of Anesthesiology Renji Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

10000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen Hua

Facility Name

Zhejiang Tumor Hospital

City

Zhejiang

State/Province

Hangzhou

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanhong Lian

Facility Name

Dalian Municipal Friendship Hospital

City

Dalian

State/Province

Liaoning

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Wang

Phone

13591732255

13591732255@163.com

Facility Name

Renji Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diansan Su

Phone

+862168383702

diansansu@yahoo.com

Facility Name

The Second Hospital of Shanxi Medical University

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linzhong Zhang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs