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Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

Primary Purpose

Gastric Cancer, Gastric Ulcer, Intestinal Polyps

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ciprofol

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring sedation, gastrointestinal endoscopy, obese patient, ciprofol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age, ≤18 and ≤60 years, no gender limit
Undergoing routine gastrointestinal endoscopic diagnosis and treatment
American Society of Anesthesiologists (ASA) classification I-II
Body Mass Index(BMI) ≥28kg/m^2
Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion Criteria:

Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
Drug abuse history within 3 months before the screening period
People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
The researcher believes that patients should not participate in this trial

Sites / Locations

Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ciprofol group

Arm Description

Outcomes

Primary Outcome Measures

Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.

Secondary Outcome Measures

Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.

Full Information

NCT ID

NCT05517408

First Posted

August 24, 2022

Last Updated

August 15, 2023

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05517408

Brief Title

Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

Official Title

Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 19, 2022 (Actual)

Primary Completion Date

November 3, 2022 (Actual)

Study Completion Date

August 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi 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 anesthetic, which combines 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 sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.

6. Conditions and Keywords

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

Gastric Cancer, Gastric Ulcer, Intestinal Polyps, Intestinal Cancer

Keywords

sedation, gastrointestinal endoscopy, obese patient, ciprofol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ciprofol group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ciprofol

Intervention Description

The first patient received Ciprofol 0.3mg/kg (actual body weight) at a rate of 1 mg/s. If the desired depth of sedation/anesthesia reached, then it was judged as negative, and the dose of Ciprofol in next patient would be decreased by one concentration gradient (the difference between two adjacent drugs was 1:1.1); If the desired sedation/anesthesia depth was not achieved, then it was judged as positive. And the dose of Ciprofol in next patient would be increased by one concentration gradient. Patients were enrolled consecutively until the trial was terminated at the eighth crossing point (positive to negative or negative to positive).

Primary Outcome Measure Information:

Title

Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.

Time Frame

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

Secondary Outcome Measure Information:

Title

Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.

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

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age, ≤18 and ≤60 years, no gender limit Undergoing routine gastrointestinal endoscopic diagnosis and treatment American Society of Anesthesiologists (ASA) classification I-II Body Mass Index(BMI) ≥28kg/m^2 Clearly understand and voluntarily participate in the study; provide signed informed consent Exclusion Criteria: Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits) Drug abuse history within 3 months before the screening period People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc The researcher believes that patients should not participate in this trial

Central Contact Person:

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

diansan su, PhD

Phone

18616514088

diansansu@yahoo.com

Facility Information:

Facility Name

Renji Hospital

City

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

diansan su, PhD

Phone

18616514088

diansansu@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We have no plan to share individual participant data.

Learn more about this trial

Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

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