Clinical trial
Clinical Use of Ciprofol in Painless Colonoscopy: a Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study
Name
GYSDYRMYY
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2022-12-01
Trial end
2023-04-30
Status
Completed
Treatment
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.
Arms:
Propofol group
Ciprofol
Ciprofol
Arms:
Ciprofol ground
Size
110
Primary endpoint
the incidence of hypotension
Day 1
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour before the start of treatment.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}
Updated at
2023-11-30
1 organization
2 products
1 indication
Organization
Sichuan Provincial People's HospitalProduct
PropofolIndication
Induction of AnesthesiaProduct
Ciprofol