Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients

Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients: an Exploratory Study Based on Dixon's Up-and-Down Method

ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. In the context of general anesthesia induction, recent research has confirmed a 100% success rate in the induction of general anesthesia for elderly patients (65-80 years old) undergoing non-cardiac surgery with a dosage range of 0.2mg/kg-0.4mg/kg ciprofol. However, for elderly patients aged 65 and above, even up to 85 years old, it is currently not entirely clear what dosage should be selected for patients in different age groups. Consequently, we have designed this trial with the aim of exploring the dosage requirements of ciprofol during general anesthesia induction among elderly patients in various age brackets.

Methods: This is a prospective, non-controlled, non-randomized, single-blind study. Elderly patients aged 65 years and older were enrolled in the study with American Society of Anesthesiologists (ASA) physical status I or II undergoing general anesthesia. All patients were divided into five groups according to age, and the corresponding initial dose of ciprofol administered was selected according to the grouping, with subsequent doses of ciprofol determined according to the Dixon up-and-down method. At least seven crossover points were obtained before the conclusion of the study.The primary outcomes were the dose of ciprofol administered at the time of loss of consciousness (mg/Kg) and the plasma concentration of ciprofol.

Study Overview

• Status: Recruiting
• Conditions: Elderly Patients
• Intervention / Treatment: Drug: Ciprofol dose 0.4mg/Kg; Drug: Ciprofol dose 0.3mg/Kg; Drug: Ciprofol dose 0.2mg/Kg

Detailed Description

After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB-2024-76(IIT)). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. The study was performed from Jan 1, 2024 to Dec 31, 2025. 150 patients aged 65 years and above, ASA physical status I or II, undergoing surgery under general anesthesia and who were not allergic to the study drug were included in this study. Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. All patients were divided into five groups according to age, The initial dose of ciprofol for the first elderly patient was 0.2-0.4 mg/kg, the initial concentration was 0.4 mg/Kg for patients aged 65-74 years, 0.3 mg/Kg for patients aged 75-84 years, and 0.2 mg/Kg for patients aged 85 years or older, and the ciprofol doses for adjacent patients were set to be equidistantly spaced up and down by 0.05 mg/kg. Evaluation of the eyelash reflex and speech reflex was performed after intravenous infusion of ciprofol to observe whether LOC occurred within 4 min. After loss of consciousness, sufentanil (5ug/ml, diluted in 0.9% saline) and rocuronium bromide were given for endotracheal intubation.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaochun Jin; Phone Number: +8657188122564; Email: ec@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Jiangling Wang
      • Principal Investigator: Jiangling Wang, Dr.
      • Contact: Jiangling Wang, Dr.; Phone Number: +8615168373331; Email: wangjl@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 65 ≤ age years;
• ASA physical state I and II;
• Hadn't a history of allergy to the drugs used in this study;

Exclusion Criteria:

• America Society of Anesthesiologists (ASA) class >III;
• Allergic to anesthetic solutions or the drugs used in this study;
• Body mass index (BMI) ≤ 20 or ≥ 30 kg/m2;
• Using hypnotics, opioid analgesics, or anti-anxiety medications;
• Known or suspected heart failure (ejection fraction <40%), severe respiratory disease, renal or metabolic disease
• Refuse to participate or participate with other clinical investigators ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 65-69 years old; The initial dose of ciprofol was 0.4mg/ in this group.	Drug: Ciprofol dose 0.4mg/Kg; The initial dose of ciprofol was 0.4mg/Kg for induction in this group.; Other Names: 0.4mg/Kg ciprofol
Experimental: 70-74 years old; The initial dose of ciprofol was 0.4mg/ in this group.	Drug: Ciprofol dose 0.4mg/Kg; The initial dose of ciprofol was 0.4mg/Kg for induction in this group.; Other Names: 0.4mg/Kg ciprofol
Experimental: 75-79 years old; The initial dose of ciprofol was 0.3mg/ in this group.	Drug: Ciprofol dose 0.3mg/Kg; The initial dose of ciprofol was 0.3mg/Kg for induction in this group.; Other Names: 0.3mg/Kg ciprofol
Experimental: 80-84 years old; The initial dose of ciprofol was 0.3mg/ in this group.	Drug: Ciprofol dose 0.3mg/Kg; The initial dose of ciprofol was 0.3mg/Kg for induction in this group.; Other Names: 0.3mg/Kg ciprofol
Experimental: Older than 85 years (include 85 years old); The initial dose of ciprofol was 0.2mg/ in this group.	Drug: Ciprofol dose 0.2mg/Kg; The initial dose of ciprofol was 0.2mg/Kg for induction in this group.; Other Names: 0.2mg/Kg ciprofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ciprofol EC50 (mg/Kg) for loss of consciousness	Use up-and-down method to evaluate the Ciprofol EC50 for loss of consciousness in different age groups.	From loss of consciousness (LOC) to 10 minutes after trachea intubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of ciprofol when LOC.	Measure the plasma concentration of ciprofol when LOC.	From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
The mean artery pressure	Hemodynamic fluctuation during induction	From entering the OR to 10 minutes after trachea intubation.
The heart rate	Hemodynamic fluctuation during induction	From entering the OR to 10 minutes after trachea intubation.
Incidence of adverse events	Measuring and recording the adverse events such as hypotension, hypertension, bradycardia and tachycardia during induction period.	From entering the OR to 10 minutes after trachea intubation.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Study Chair: Ji Zhu, Dr., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Ciprofol; General anesthesia; EC50; Los of consciousness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: IRB-2024-76（IIT）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan can be shared when required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No