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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol group | Placebo Comparator | The initial dose of propofol was 2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score =0), the colonoscopy will commence. If subjects' MOAA/S score ≥ 1 point, additional administration of cyclopofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was 0 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after colonoscopy: In order to maintain a certain degree of sedation after colonoscopy (MOAA/S score ≤1 point), the evaluator decides when to administer additional drugs. Additional administration of propofol: The additional dose was 0.5mg/kg/ time, and intravenous bolus was administered. |
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| Ciprofol ground | Experimental | The initial dose of ciprofol was 0.4mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score =0), the colonoscopy will begin; If subjects' MOAA/S score ≥ 1 point, additional administration of ciprofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was 0 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after colonoscopy: In order to maintain a certain degree of sedation after colonoscopy (MOAA/S score ≤1 point), the evaluator decides when to administer additional drugs. Ciprofol supplemental administration: the supplemental dose was 0.1mg/kg/ time, and intravenous bolus was administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the successful sedation time | When the Patients'MOAA/S was 0 as the successful sedation time | 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) |
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Inclusion Criteria:
4. American Society of Anesthesiologists (ASA) grades ⅰ ~ ⅲ
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchang Yang | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Participants were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour before the start of treatment.
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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.
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| Ciprofol | Drug | Ciprofol |
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| 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) | 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) | 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) | Day 1 |
| Steward wakefulness Score | Minimum value =0, maximum value =6, the higher the score, the higher the degree of wakefulness | Day 1 |
| Directional force score | Minimum value =0, maximum value =10, the higher the score, the higher the degree of directivity | Day 1 |
| Incidence of adverse events | including injection pain, intraoperative muscle fibrillation, hypoxemia, body movement, and postoperative complications | Day 1 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |