Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

NCT05294679 | Completed

• 1 other identifier: GYSDYRMYY
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study used propofol as a positive control, and adopted a large-sample, multi-center, randomized, double-blind, positive parallel controlled trial design to explore the clinical application value of ciprofol in painless colonoscopy.

Conditions

Induction of Anaesthesia

Keywords

Propofol; Ciprofol

Outcome Measures

Primary Outcomes (1)

• the incidence of hypotension

  Perioperative hypotension was defined as systolic blood pressure below 90mmHg, diastolic blood pressure below 50mmHg, or systolic blood pressure below baseline

  Day 1

Secondary Outcomes (8)

• the successful sedation time

  Day 1

• Blood pressure

  Day 1

• Heart rate

  Day 1

• Respiratory rate

  Day 1

• Oxygen saturation（SpO2 %）

  Day 1

Study Arms (2)

Propofol group

PLACEBO COMPARATOR

The initial dose of propofol was 2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score =0), the colonoscopy will commence. If subjects' MOAA/S score ≥ 1 point, additional administration of cyclopofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was 0 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after colonoscopy: In order to maintain a certain degree of sedation after colonoscopy (MOAA/S score ≤1 point), the evaluator decides when to administer additional drugs. Additional administration of propofol: The additional dose was 0.5mg/kg/ time, and intravenous bolus was administered.

Drug: Propofol

Ciprofol ground

EXPERIMENTAL

The initial dose of ciprofol was 0.4mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score =0), the colonoscopy will begin; If subjects' MOAA/S score ≥ 1 point, additional administration of ciprofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was 0 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after colonoscopy: In order to maintain a certain degree of sedation after colonoscopy (MOAA/S score ≤1 point), the evaluator decides when to administer additional drugs. Ciprofol supplemental administration: the supplemental dose was 0.1mg/kg/ time, and intravenous bolus was administered.

Drug: Ciprofol

Interventions

Propofol DRUG

All patients completed pre-anaesthesia assessment, signed informed consent, and completed vital signs on the day before surgery, with values as baseline vital signs. On the day of surgery, after routine preparation before colonoscopy (fasting for at least 6h and water restriction for at least 2h before surgery), venous access was established in the left hand. 0.5μg/kg fentanyl was administered intravenously after oxygen inhalation through a nasal catheter (4-6 L/min). About 3 minutes after fentanyl administration, sedation induction was performed with ciprofol or propofol immediately.

Propofol group

Ciprofol DRUG

Ciprofol

Ciprofol ground

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing painless colonoscopy;
• Patients aged from 18 to 80 years old, no gender limitation; 3, 18 \< BMI \< 30kg/m2 \[BMI = weight (kg)/ height (m) squared\]
• \. American Society of Anesthesiologists (ASA) grades ⅰ \~ ⅲ

You may not qualify if:

• Preoperative blood pressure \>160/100 mmHG or \< 80/50 mmHG.
• Preoperative ecg suggested heart rate \<50 times/min;
• Acute respiratory tract infection with no cured history within 2 weeks;
• People with serious metabolic diseases such as heart, brain, lung, liver, kidney and diabetes;
• Predict people who may have or have had difficult airway;
• Patients with obvious electrolyte disorders such as hyperkalemia;
• Long-term use of immunosuppressants such as hormones or history of adrenocortical inhibition;
• People who are known to be allergic to emulsions and opioids;
• Preoperative combined use of other sedative and analgesic drugs
• Suspected abuse of narcotic analgesics or sedatives; 11, there are neuromuscular system diseases, mental diseases and other people do not cooperate with the communication;

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Mengchang Yang

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, evaluation researchers and drug administration researchers were set up. The whole process of the experiment was blind not only to the subjects, but also to the evaluation researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Participants were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour before the start of treatment.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 24, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)