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

NCT06258967 | Unknown

• 1 other identifier: 2023ZSLYEC-636
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Induction Hypotension; Elderly

Outcome Measures

Primary Outcomes (1)

• The difference in the incidence of hypotension occurring 15 minutes after successful intubation between the two groups.

  Hypotension is defined as a mean arterial pressure (MAP) of 65 mmHg or lower. The occurrence of hypotension in each group will be documented.

  From successful tracheal intubation to 15 minutes later.

Secondary Outcomes (16)

• Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) < 65 mmHg.

  From successful tracheal intubation to 15 minutes later.

• 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.

  From successful tracheal intubation to 15 minutes later.

• Time-weighted area between the curve of blood pressure and the target MAP(110mmHg,120mmHg) during the post-induction period

  From successful tracheal intubation to 15 minutes later.

• The dose of norepinephrine used during the induction and post-induction periods.

  From the administration of general anesthesia with an induction drug to 15 minutes after tracheal intubation has been completed.

• Total time for patient loss of consciousness

  During anesthesia induction

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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.

Drug: propofol

Ciprofol

EXPERIMENTAL

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.

Drug: ciprofol

Interventions

ciprofol DRUG

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

Ciprofol

propofol DRUG

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

Propofol

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 14, 2024
• Study Start: February 20, 2024
• Primary Completion: December 24, 2024
• Study Completion: December 31, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-01

Locations

CN (1)