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

May 4, 2026 updated by: SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510655
        • Not yet recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: controled group
Patients in this group will undergo anesthesia induction and maintenance with ciprofol and remifentanil. Induction will be performed with intravenous bolus administration of ciprofol at a dose of 0.4 mg/kg and remifentanil at a dose of 1.2μg/kg, followed by a neuromuscular blocker to facilitate tracheal intubation. During surgery, anesthetic doses will be adjusted at the discretion of the anesthesiologist, based on the patient's physiological parameters and surgical conditions. BIS monitoring is applied and the screen remains visible to the anesthesiologist. However, ciprofol dose adjustments are made according to routine clinical judgement without reference to a prespecified BIS target or structured titration rule.
Experimental: titrated group
In this group, anesthesia induction is performed with continuous infusion of ciprofol until loss of consciousness (OAA/S score = 1). Remifentanil 1.2 μg/kg is then administered, followed by a neuromuscular blocker to facilitate tracheal intubation. After intubation, anesthesia was maintained with ciprofol (0.4-3 mg/kg/h) and remifentanil (0.01-0.5 µg/kg/min) until the end of surgery. Depth of anesthesia was adjusted intraoperatively to maintain BIS at approximately 50.
Drug: titrated anesthesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intraoperative hypotension.
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Hypotension is defined as at least one episode of mean arterial pressure (MAP) <65 mmHg sustained for at least 1 minute.
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
calculated as AUC / total time of anesthesia
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
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.
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
caculate as area under the curve / total anesthesia time
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time to first hypotension
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The time to first hypotension during anesthesia
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The time periods with a higher incidence of hypotension between the two groups
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The time is divided into four parts: induction period, post-induction period, surgical period, and early postoperative period
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Total dose of ciprofol and remifentanil during surgery
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The total doses of ciprofol and remifentanil administered per hour throughout the entire surgical procedure.
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Whether blood pressure variability (CV) and the average rate of blood pressure variation (ARV) are different.
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Both CV and ARV will be calculated using the formulas provided in the reference literature.
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The incidence of severe intraoperative hypotension
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Severe intraoperative hypotension is defined as MAP < 55 mmHg
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time from discontinuation of anesthetic drugs to awakening.
Time Frame: From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.
Awakening is defined as the first eye opening in response to a verbal command.
From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.
the rate of postoperative delirium
Time Frame: Postoperatively (4-6 hours), Day 1, Day 2, Day 3
Postoperative delirium is assessed using the Chinese version of the 3D-CAM scale. The Chinese version of the 3D-CAM has a sensitivity ranging from 84.6% to 87.2% and a specificity ranging from 96.7% to 97.4%. If a patient is admitted to the ICU, the CAM-ICU scale will be used to evaluate them for delirium.
Postoperatively (4-6 hours), Day 1, Day 2, Day 3
Postoperative complications
Time Frame: 30 days after the operation
The evaluation of postoperative complications will be conducted using Futier's classification system for postoperative complications, with the primary basis for assessment being medical record data and follow-up data.
30 days after the operation
All-cause mortality within 30 days after surgery.
Time Frame: 30 days after operation
All-cause mortality is defined as death from any cause occurring within 30 days following surgery.
30 days after operation
Hospital readmission within 30 days after surgery
Time Frame: 30 days postoperatively.
Readmission is defined as any unplanned hospital admission occurring within 30 days after surgery.
30 days postoperatively.
The lowest MAP during anesthesia
Time Frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The lowest MAP during anesthesia
From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
CI trend during anesthesia
Time Frame: From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.
CI data will be collected by the device and extracted for analysis.
From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025ZSLYEC-415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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