RecruitingPhase 4NCT06253078

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


Sponsor

Zhejiang Cancer Hospital

Enrollment

150 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 YearsMax Age: 105 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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 ;

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Interventions

DRUGCiprofol dose 0.4mg/Kg

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

DRUGCiprofol dose 0.3mg/Kg

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

DRUGCiprofol dose 0.2mg/Kg

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


Locations(1)

Jiangling Wang

Hangzhou, Zhejiang, China

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NCT06253078


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