Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2023
Source Sichuan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00965107 - Onset Time of Thiopental Versus Propofol in the Elderly Phase 4
Completed NCT02186990 - Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation Phase 4
Completed NCT00506246 - Efficacy and Safety Study of Two Propofol Formulations Phase 3
Completed NCT02287181 - A Phase IV Study Investigating the Effects of Remifentanil Concentrations on Propofol Requirements for Loss of Consciousness, Response to Painful Stimuli, Bispectral Index and Associated Haemodynamic Changes Phase 4