Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

NCT ID: NCT05294679

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-04-30

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.

Detailed Description

Subjects were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour prior to diagnosis and treatment. A centralized random grouping method was used in this study. After screening subjects, the researchers in each test center will log in to the random system after being confirmed by the researchers of the center, fill in the screening information, obtain the random number information, and issue the corresponding study drugs according to the random number. Random shelter number was generated by SAS software, and was used as the total blind base pair drug number and imported into the centralized random grouping system. 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. Evaluation investigators and administration investigators were set up in this study. The administration investigators were only involved in the process of random grouping, drug dispensing and administration, and the other processes including informed consent of subjects, screening, evaluation of efficacy indicators and safety, and planned visits were all completed by the evaluation investigators.

Conditions

Induction of Anaesthesia

Keywords

Propofol; Ciprofol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propofol group

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.

Group Type: PLACEBO_COMPARATOR

Propofol

Intervention Type: 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.

Ciprofol ground

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.

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

Ciprofol

Interventions

Propofol

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.

Intervention Type: DRUG

Ciprofol

Ciprofol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing painless colonoscopy;

2. Patients aged from 18 to 80 years old, no gender limitation; 3, 18 < BMI < 30kg/m2 [BMI = weight (kg)/ height (m) squared]

4. American Society of Anesthesiologists (ASA) grades ⅰ ~ ⅲ

Exclusion Criteria

1. Preoperative blood pressure >160/100 mmHG or < 80/50 mmHG.

2. Preoperative ecg suggested heart rate <50 times/min;

3. Acute respiratory tract infection with no cured history within 2 weeks;

4. People with serious metabolic diseases such as heart, brain, lung, liver, kidney and diabetes;

5. Predict people who may have or have had difficult airway;

6. Patients with obvious electrolyte disorders such as hyperkalemia;

7. Long-term use of immunosuppressants such as hormones or history of adrenocortical inhibition;

8. People who are known to be allergic to emulsions and opioids;

9. Preoperative combined use of other sedative and analgesic drugs

10. Suspected abuse of narcotic analgesics or sedatives; 11, there are neuromuscular system diseases, mental diseases and other people do not cooperate with the communication;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mengchang Yang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mengchang Yang

Chengdu, Sichuan, China

Countries

China

Other Identifiers

GYSDYRMYY

Identifier Type: -

Identifier Source: org_study_id