Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

Induction of Anaesthesia Clinical Trial

Official title:

Clinical Use of Ciprofol in Painless Colonoscopy: a Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294679
• Other study ID #: GYSDYRMYY
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ? ~ ?

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;

Related Conditions & MeSH terms

• Induction of Anaesthesia

Intervention

Drug:
• 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.
• Ciprofol
Ciprofol

Locations

Country	Name	City	State
China	Mengchang Yang	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the successful sedation time	When the Patients'MOAA/S was 0 as the successful sedation time	Day 1
Secondary	Blood pressure	Record the blood pressure at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)	Day 1
Secondary	Heart rate	Record the heart rate at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)	Day 1
Secondary	Respiratory rate	Record the respiratory rate at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)	Day 1
Secondary	Oxygen saturation(SpO2 %)	Record the oxygen satuaition at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)	Day 1
Secondary	Steward wakefulness Score	Minimum value =0, maximum value =6, the higher the score, the higher the degree of wakefulness	Day 1
Secondary	Directional force score	Minimum value =0, maximum value =10, the higher the score, the higher the degree of directivity	Day 1
Secondary	Incidence of adverse events	including injection pain, intraoperative muscle fibrillation, hypoxemia, body movement, and postoperative complications	Day 1