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
NCT number | NCT05294679 |
Other study ID # | GYSDYRMYY |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | April 30, 2023 |
Verified date | November 2023 |
Source | Sichuan Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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; |
Country | Name | City | State |
---|---|---|---|
China | Mengchang Yang | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan Provincial People's Hospital |
China,
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 |
Status | Clinical Trial | Phase | |
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Completed |
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