Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients

NCT06253078 | Recruiting Phase 4 DMC

• 1 other identifier: IRB-2024-76（IIT）
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ciprofol; EC50; Los of consciousness; Elderly; General anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  From entering the OR to 10 minutes after trachea intubation.

• The heart rate

  From entering the OR to 10 minutes after trachea intubation.

• Incidence of adverse events

  From entering the OR to 10 minutes after trachea intubation.

Study Arms (5)

65-69 years old

EXPERIMENTAL

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

Drug: Ciprofol dose 0.4mg/Kg

70-74 years old

EXPERIMENTAL

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

Drug: Ciprofol dose 0.4mg/Kg

75-79 years old

EXPERIMENTAL

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

Drug: Ciprofol dose 0.3mg/Kg

80-84 years old

EXPERIMENTAL

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

Drug: Ciprofol dose 0.3mg/Kg

Older than 85 years (include 85 years old)

EXPERIMENTAL

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

Drug: Ciprofol dose 0.2mg/Kg

Interventions

Ciprofol dose 0.4mg/Kg DRUG

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

Also known as: 0.4mg/Kg ciprofol

65-69 years old; 70-74 years old

Ciprofol dose 0.3mg/Kg DRUG

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

Also known as: 0.3mg/Kg ciprofol

75-79 years old; 80-84 years old

Ciprofol dose 0.2mg/Kg DRUG

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

Also known as: 0.2mg/Kg ciprofol

Older than 85 years (include 85 years old)

Eligibility Criteria

• Age: 65 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Jiangling Wang

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Study Officials

• Ji Zhu, Dr.

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Xiaochun Jin

CONTACT

+8657188122564; ec@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 12, 2024
• Study Start: April 2, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)