Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients (NCT06258967) | Clinical Trial Compass
UnknownNot Applicable
Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients
China160 participantsStarted 2024-02-20
Plain-language 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.
Who can participate
Age range65 Years – 90 Years
SexALL
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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 disabili…
What they're measuring
1
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.
Trial details
NCT IDNCT06258967
SponsorSixth Affiliated Hospital, Sun Yat-sen University