Clinical trial NCT05294679: Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy
Official title: Clinical Use of Ciprofol in Painless Colonoscopy: a Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Anaesthesia
Keywords: Propofol
Ciprofol
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour before the start of treatment.
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: the incidence of hypotension
timeFrame: Day 1
Secondary outcomes:
measure: the successful sedation time
timeFrame: Day 1
measure: Blood pressure
timeFrame: Day 1
measure: Heart rate
timeFrame: Day 1
measure: Respiratory rate
timeFrame: Day 1
measure: Oxygen saturation（SpO2 %）
timeFrame: Day 1
measure: Steward wakefulness Score
timeFrame: Day 1
measure: Directional force score
timeFrame: Day 1
measure: Incidence of adverse events
timeFrame: Day 1
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Mengchang Yang
state: Sichuan
Study officials:
References: