Clinical trial NCT06258967: Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients
Official title: A Prospective Randomized Controlled Trail of Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Induction Hypotension
Elderly
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The difference in the incidence of hypotension occurring 15 minutes after successful intubation between the two groups.
timeFrame: From successful tracheal intubation to 15 minutes later.
Secondary outcomes:
measure: Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) < 65 mmHg.
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: Time-weighted area under the curve of blood pressure during the induction and post-induction phases of anesthesia with a mean arterial pressure (MAP) ≤ 70% of the baseline value.
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: Time-weighted area between the curve of blood pressure and the target MAP(110mmHg,120mmHg) during the post-induction period
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: The dose of norepinephrine used during the induction and post-induction periods.
timeFrame: From the administration of general anesthesia with an induction drug to 15 minutes after tracheal intubation has been completed.
measure: Total time for patient loss of consciousness
timeFrame: During anesthesia induction
measure: Trends in CO( cardiac output)
timeFrame: from 1min before aneshesia induction until 20minuts after study durg administered.
measure: Incidence of agitation during the post-anesthesia recovery period and early postoperative delirium .
timeFrame: 30min and 1hour after patients arrived the PACU
measure: Incidence of perioperative awareness
timeFrame: 1,2,3 days postoperatively
measure: Incidence of postoperative nausea and vomiting
timeFrame: postoperative 1,2,3days
measure: Incidence of Postoperative delirium
timeFrame: 1,2,3days postoperatively
measure: Incidence of complications within 7 days postoperatively.
timeFrame: 7 days postoperatively.
measure: The difference of Postoperative Quality of Recovery-15 (QoR-15) score.
timeFrame: 1,2,3 days postoperatively
measure: Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) <55 mmHg.
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) ≥140 mmHg.
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >110 mmHg.
timeFrame: From successful tracheal intubation to 15 minutes later.
measure: Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >120 mmHg.
timeFrame: From successful tracheal intubation to 15 minutes later.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: