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Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients

NCT06253078 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Elderly Patients

Interventions

DRUG

Ciprofol dose 0.4mg/Kg

The initial dose of ciprofol was 0.4mg/Kg for induction in this group.

DRUG

Ciprofol dose 0.3mg/Kg

The initial dose of ciprofol was 0.3mg/Kg for induction in this group.

DRUG

Ciprofol dose 0.2mg/Kg

The initial dose of ciprofol was 0.2mg/Kg for induction in this group.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Ji Zhu, Dr. · Zhejiang Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06253078 on ClinicalTrials.gov