Actively Recruiting

Phase 4
Age: 65Years - 105Years
All Genders
NCT06253078

Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients

Led by Zhejiang Cancer Hospital · Updated on 2024-05-29

150

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients

Who Can Participate

Age: 65Years - 105Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • ASA physical status I or II
  • No history of allergy to study drugs
Not Eligible

You will not qualify if you...

  • ASA physical status above III
  • Allergy to anesthetic drugs or solutions used in this study
  • Body mass index less than 20 or greater than 30 kg/m2
  • Current use of hypnotics, opioid analgesics, or anti-anxiety medications
  • Known or suspected heart failure with ejection fraction below 40%
  • Severe respiratory disease
  • Renal or metabolic disease
  • Refusal to participate or involvement in other clinical trials

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Jiangling Wang

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

X

Xiaochun Jin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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