Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- ASA physical status I or II
- No history of allergy to study drugs
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
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Trial Site Locations
Total: 1 location
1
Jiangling Wang
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
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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