Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

Sichuan Provincial People's Hospital110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Induction of Anaesthesia

Interventions

PropofolDRUG

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.

CiprofolDRUG

Ciprofol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Mengchang Yang

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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

Time frame: Day 1

Secondary Outcomes

the successful sedation time

When the Patients'MOAA/S was 0 as the successful sedation time

Time frame: Day 1

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)

Time frame: Day 1

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)

Time frame: Day 1

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)

Time frame: Day 1

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)

Data from ClinicalTrials.gov

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