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

NCT05517408 | Unknown

• 1 other identifier: diansansu0722
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastric Ulcer; Intestinal Polyps; Intestinal Cancer

Keywords

sedation; gastrointestinal endoscopy; obese patient; ciprofol

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

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

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

Study Arms (1)

Ciprofol group

EXPERIMENTAL

Drug: ciprofol

Interventions

ciprofol DRUG

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).

Ciprofol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Stomach Ulcer; Intestinal Polyps; Intestinal Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

diansan su, PhD

CONTACT

18616514088; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 19, 2022
• Primary Completion: November 3, 2022
• Study Completion: August 13, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)