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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • titrated anesthesia

    Drug

    Anesthesia induction and maintenance will be performed with ciprofol and remifentanil. During the entire procedure, infusion rates will be adjusted according to a target BIS value of approximately 50, with anesthetic dosing continuously modified in response to BIS monitoring. The attending anesthesiologist will titrate anesthetic delivery based on BIS guidance rather than routine clinical judgment alone.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: controled groupNo intervention 0 interventions
Group B: titrated groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of intraoperative hypotension.

Hypotension is defined as at least one episode of mean arterial pressure (MAP) \<65 mmHg sustained for at least 1 minute.

Time frame
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

Secondary outcomes

1

the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period

calculated as AUC / total time of anesthesia

Time frame
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
2

cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;

the cumulative dose of norepinephrine administered intraoperatively (µg) and the proportion of patients who required any vasoactive medication (norepinephrine, dopamine, or ephedrine) during the anesthesia period.

Time frame
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
3

the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period

caculate as area under the curve / total anesthesia time

Time frame
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
4

Time to first hypotension

The time to first hypotension during anesthesia

Time frame
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

Other outcomes

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