Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients

NCT ID: NCT06258967

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-12-31

Brief Summary

Geriatric patients undergoing general anesthesia face a significant challenge, with the induction phase contributing to 50% of hypotensive events.

Titrated anesthesia, involving gradual drug administration, suits elderly induction. However, propofol in titrated anesthesia tends to induce hypotension. In contrast, Ciprofol (HSK3486), a novel anesthetic, reduces hypotension during induction. This study compares hypotension incidences during induction and post-induction phases, agitation rates during recovery, perioperative awareness, postoperative delirium, and parameters in elderly patients induced with Ciprofol versus propofol through titrated anesthesia. The goal is to clarify a medically optimized anesthesia protocol for elderly patients during titrated anesthesia induction in general anesthesia.

Detailed Description

As the global population ages, there is a growing demand for surgical interventions among the elderly. However, this demographic is concurrently faced with an increased susceptibility to postoperative complications. Notably, the geriatric population undergoing general anesthesia exhibits a higher incidence of hypotension, intricately linked with a spectrum of postoperative issues. The induction phase of general anesthesia, constituting 50% of hypotensive events, presents a significant challenge in mitigating hypotension.

Titrated anesthesia, characterized by gradual and individualized drug administration, emerges as a suitable approach for the induction of general anesthesia in the elderly. Nevertheless, the administration of propofol through titrated anesthesia maintains an observable tendency to induce hypotension.

In contrast, Ciprofol (HSK3486), a novel anesthetic agent, demonstrates a reduced propensity for precipitating hypotension during the induction of anesthesia. This investigative study aims to meticulously examine and compare the incidences of hypotension during both the induction and post-induction phases. Furthermore, it endeavors to delineate differences in the rates of agitation during the recovery phase, perioperative awareness, postoperative delirium, and other relevant parameters among elderly patients induced with ciprofol versus propofol via titrated anesthesia.

A sample size of 80 patients in each group will be selected by a prior power analysis on the basis of the following assumptions: (1) the rate of hypotension in group Propofol was 57%; and 30%in group Cipropfol (2)α=0.05, (4) power 90% and .(5) missed follow-up rate 12%.

After obtaining informed consent, all participants will be randomized to one of the trial groups using a stratified method. A 20G catheter will be inserted into the radial artery before anesthesia induction. Vital signs will be recorded from 3 minutes before general induction until 15 minutes after tracheal intubation. Participants in Group P will undergo induction with propofol, starting at a rate of 15mg/kg/h until loss of consciousness, followed by an adjustment to a slower infusion rate. In contrast, Group C will receive ciprofol at a rate of 3mg/kg/h. Following the intervention period, all participants will receive sevoflurane and remifentanil until the conclusion of the surgery. Both groups will be followed up for 7 days postoperatively to assess perioperative awareness, postoperative delirium, quality of recovery, and postoperative complications.

Conditions

Post Induction Hypotension; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Propofol

Propofol is administered at a rate of 15mg/kg\*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 5mg/kg/h and make further dose adjustments based on the patient's response and BIS value, with increments or decrements ranging from 1mg/kg/h, within a total range of 3-8mg/kg/h.

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

Patients receive propofol as general anesthesia induction drug, using the titrated anesthesia method.

Ciprofol

Cprofol is administered at a rate of 3mg/kg\*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 1mg/kg/h and make further dose adjustments based on the patient's response, with increments or decrements ranging from 0.2mg/kg/h, within a total range of 0.6-1.6mg/kg/h.

Group Type: EXPERIMENTAL

ciprofol

Intervention Type: DRUG

Patients receive ciprofol as general anesthesia induction drug, using the titrated anesthesia method.

Interventions

ciprofol

Patients receive ciprofol as general anesthesia induction drug, using the titrated anesthesia method.

Intervention Type: DRUG

propofol

Patients receive propofol as general anesthesia induction drug, using the titrated anesthesia method.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years and age < 90 years.
• ASA (American Society of Anesthesiologists) physical status classification 1-3.
• Scheduled for elective general anesthesia surgery.

Exclusion Criteria

• Participants already enrolled in other studies or those already assigned in this study .
• BMI (Body Mass Index) ≤ 18 or ≥ 30 kg/m2.
• Preoperative assessment indicating a challenging airway or a risk of aspiration, requiring a slow induction for intubation.
• Presence of severe liver or kidney disease (GFR ≤ 30 ml/min/1.73m2 or requiring renal replacement therapy; Child-Pugh class C for liver function).
• Patients with severe uncontrolled hypertension (preoperative SBP ≥ 180 mmHg or DBP ≥ 110 mmHg).
• Individuals with arrhythmias and severe valvular diseases, including high-degree atrioventricular block (Mobitz type II or third-degree block); symptomatic bradycardia; symptomatic ventricular arrhythmias; prolonged Q-T interval; supraventricular arrhythmias combined with an uncontrolled ventricular rate > 100 bpm (at rest); new-onset ventricular tachycardia; uncontrolled atrial fibrillation (ventricular rate ≥ 110 bpm); atrial flutter; severe aortic valve stenosis (mean pressure gradient > 40 mmHg; valve area < 1 cm2; symptomatic); severe mitral valve stenosis (progressive breathlessness during exertion; exertional syncope; heart failure).
• Patients diagnosed with schizophrenia, epilepsy, Parkinson's disease, severe cognitive impairment, intellectual disability, hearing impairment.
• Individuals with a history of alcoholism or long-term use of sedatives and analgesics.
• Previous allergic reactions to medications used in this study.
• Individuals already under vasoconstrictor treatment before anesthesia induction.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hong Bai, professor

Role: primary

bhong@mail.sysu.edu.cn

+8613480250519

Other Identifiers

2023ZSLYEC-636

Identifier Type: -

Identifier Source: org_study_id