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Recruiting Not applicable NCT07328958

Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

No applicable phase (e.g. observational)
Conditions: Hypotension During Surgery

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

trial.available_in: БГ
Overview
Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management. Titrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension. It is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.
Description
This study aims to investigate whether titrated anesthesia can provide more stable hemodynamic conditions during surgery and whether this approach is associated with improved postoperative recovery in elderly patients.
Who can participate
Inclusion Criteria: * Age ≥65 years, scheduled for elective laparoscopic abdominal surgery * American Society of Anesthesiologists (ASA) physical status I-III * Requirement for invasive arterial blood pressure monitoring Exclusion Criteria: * Participation in other clinical trials that may interfere with the intervention or outcomes of this study * Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function) * Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg) * Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications; * Known allergy to drugs used in this study * Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic manipulation due to surgical factors * Anticipated blood loss \>15% of estimated blood volume * Expected surgical duration \<1 hours or \>6 hours * Expected postoperative hospital stay \<72 hours
Interventions
titrated anesthesia
DRUG
Locations 2
China (2)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou , Guangdong
NOT_YET_RECRUITING
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou , Guangdong
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
65 Years
Healthy volunteers
No
Start date
16.01.2026
Completion date
30.01.2027
Registry ID
NCT07328958
Source
clinicaltrials.gov
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