Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07328958

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

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-05-08

500

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial focuses on elderly patients undergoing laparoscopic abdominal surgery who often face higher risks of complications due to age-related health issues and increased sensitivity to anesthetic drugs. It evaluates whether adjusting anesthesia doses based on patient response during surgery can reduce low blood pressure and improve recovery compared to fixed-dose anesthesia protocols. The study assesses the impact of titrated anesthesia using ciprofol combined with remifentanil to manage perioperative hypotension in this vulnerable population. Participants are randomly assigned to one of two groups. One group receives anesthesia with fixed doses of ciprofol and remifentanil adjusted by clinical judgment without preset targets, while the other group receives titrated anesthesia guided by continuous monitoring of brain activity (BIS) to maintain a target level of sedation. Both induction and maintenance phases are covered, with drug doses tailored to individual responses. The trial compares these methods during the entire surgery period. During the study, patients will be closely monitored for blood pressure and heart function from the start of anesthesia until surgery ends, up to six hours. Researchers will track the occurrence and severity of low blood pressure episodes, medication doses used, time to awakening, and postoperative complications including delirium and hospital readmission. The follow-up period extends to 30 days after surgery to evaluate safety and recovery outcomes, ensuring comprehensive assessment of the anesthesia strategies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older, scheduled for elective laparoscopic abdominal surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Requirement for invasive arterial blood pressure monitoring
Not Eligible

You will not qualify if you...

  • Participation in other clinical trials that may interfere with this study
  • Severe liver or kidney disease (GFR �30 mL/min/1.73 m�b2, renal replacement therapy, or Child-Pugh class C)
  • Uncontrolled severe hypertension (preoperative systolic �380 mmHg or diastolic �3110 mmHg)
  • Severe mental disorders, epilepsy, Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairment, long-term alcohol abuse, or use of sedative/analgesic medications
  • Known allergy to study drugs
  • Need for continuous vasopressor infusion before surgery or prolonged hemodynamic support due to surgery
  • Expected blood loss greater than 15% of estimated blood volume
  • Expected surgery duration less than 1 hour or more than 6 hours
  • Expected postoperative hospital stay less than 72 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 6 hours during surgery

Participants undergo anesthesia induction and maintenance with ciprofol and remifentanil during laparoscopic abdominal surgery. Anesthetic dosing is adjusted based on BIS monitoring or routine clinical judgment depending on the assigned group.

1 visit (in-person) during surgery

Follow-up

Duration - Up to 30 days postoperatively

Participants are monitored for postoperative recovery including delirium, complications, mortality, and hospital readmission for up to 30 days after surgery.

Visits at 4-6 hours postoperatively, Day 1, Day 2, Day 3, and additional assessments up to 30 days

Trial Site Locations

Total: 2 locations

1

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Not Yet Recruiting

2

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

H

Hong Bai, Doctoral student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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