Clinical Observation of Ciprofol for Anesthesia Induction

• Sponsor: Xiumei Song (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05706337
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Anticipated Duration (Months): 10.9

Study Details

Study Description

Brief Summary

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Pain; Hemodynamic Instability	Drug: Propofol; Drug: Ciprofol	Phase 4

Detailed Description

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: propofol group According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.	Drug: Propofol; Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.
Experimental: ciprofol group According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups.	Drug: Ciprofol; Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.

Outcome Measures

Primary Outcome Measures

1. Hemodynamic changes：Systolic blood pressure (SBP) [From the beginning of drug administration to 30 minutes after intubation]

   Systolic blood pressure (SBP) during anesthesia induction

2. Hemodynamic changes: Diastolic blood pressure(DBP) [From the beginning of drug administration to 30 minutes after intubation]

   Diastolic blood pressure(DBP) during anesthesia induction

3. Hemodynamic changes: Heart rate （HR ） [From the beginning of drug administration to 30 minutes after intubation]

   Heart rate （HR ）during anesthesia induction

Secondary Outcome Measures

1. adverse reactions: injection pain [anesthesia induction]

   injection pain from propofol or ciprofol intravenous injection

2. adverse reactions: muscle fasciculation [anesthesia induction]

   muscle fasciculation induced by propofol or ciprofol intravenous induction

3. adverse reactions：arrhythmia [anesthesia induction]

   arrhythmia induced by propofol or ciprofol intravenous induction

4. perioperative hepatic function: Aspartate Aminotransferase ( AST) [Before surgery , 1day after operation]

   level of Aspartate Aminotransferase ( AST)

5. perioperative hepatic function: Alanine Aminotransferase ( ALT) [Before surgery , 1day after operation]

   level of Alanine Aminotransferase ( ALT)

6. perioperative renal function: creatine [Before surgery , 1day after operation]

   level of creatine

7. perioperative renal function:Blood Urea Nitrogen [Before surgery , 1day after operation]

   level of Blood Urea Nitrogen（BUN)

8. Monitoring Depth of Anesthesia [anesthesia induction]

   BIS values

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ASA physical status Ⅰ-Ⅲ

2. Age over 65 years;

3. Body mass index (BMI) 20 ~ 30 kg/m2 ;

4. Elective noncardiac surgery;

Exclusion Criteria:

1. The patient or his/her family refused to participate in the clinical trial;

2. Severe heart, lung, liver or kidney dysfunction;

3. Expected difficult airway, requiring awake tracheal intubation;

4. Those who are allergic to the drugs used in this study;

5. Unsuccessful tracheal intubation twice;

6. Patients with mental illness or impaired consciousness;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xiumei Song

Investigators

• Study Chair: Xiumei Song, Doctor, Qian fo shan hospitial of shan dong province, China

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Liu J, Wang D , Zuo Y, MI W, Yao S, Yu W. Guidelines on clinical application of ciprofol. Chin J Anesthesiol, 2021,41 (2): 129-132

Publications

• Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.
• Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
• Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.

• Responsible Party: Xiumei Song, Associate chief physician, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT05706337
• Other Study ID Numbers: YXLL-KY-2022(060)
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiumei Song, Associate chief physician, Qianfoshan Hospital: Anesthesia induction; Ciprofol; propofol; Injection pain
• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Jan 31, 2023