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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Intestinal Polyps
Gastric Cancer
Gastric Ulcer
Intestinal Cancer

Treatments

Drug: ciprofol

Study type

Interventional

Funder types

Other

Identifiers

NCT05517408
diansansu0722

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Ciprofol group
Experimental group
Treatment:
Drug: ciprofol

Trial contacts and locations

1

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Central trial contact

diansan su, PhD

Data sourced from clinicaltrials.gov

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