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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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  • 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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