Association Between Intraoperative Mean Arterial Pressure Variability and Postoperative Fatigue in Patients Undergoing Laparoscopic Abdominal Surgery

July 3, 2026 updated by: The First People's Hospital of Lianyungang

This prospective cohort study aims to investigate the relationship between intraoperative mean arterial pressure (MAP) variability and postoperative fatigue syndrome (POFS) in elderly patients (≥18 years) undergoing laparoscopic abdominal surgery. The main research question is:

Does the degree of intraoperative MAP fluctuation correlate with postoperative fatigue in elderly patients?

Eligible patients scheduled for elective laparoscopic abdominal surgery under general anesthesia will have their intraoperative blood pressure variability recorded (generalized average real variability, G-ARV), and postoperative fatigue and recovery will be assessed on postoperative days 1, 3, and 7 using the Christensen fatigue scale.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
366

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 博士
      • Lianyungang, 博士, China, 222061
        • Lianyungang

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes adult patients undergoing elective laparoscopic abdominal surgery at Lianyungang First People's Hospital. Participants will be monitored for intraoperative mean arterial pressure variability and postoperative fatigue. Patients must be capable of completing postoperative assessments on days 1, 3, and 7.

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. ASA physical status I-III;
  3. Scheduled for elective laparoscopic abdominal surgery under general anesthesia.

Exclusion Criteria:

  1. Severe cardiac, hepatic, or renal insufficiency, or major neurological or psychiatric disorders;
  2. Known allergy to drugs used during the study;
  3. Participation in other clinical trials within the past 3 months;
  4. Unable to complete the required questionnaires or assessments;
  5. Surgery duration < 60 minutes.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Low MAP Variability (LV)
Patients are categorized based on intraoperative mean arterial pressure variability measured by generalized average real variability (G-ARV). The LV group includes patients with G-ARV ≤ 33rd percentile, the MV group includes patients with G-ARV between the 34th and 67th percentile, and the HV group includes patients with G-ARV > 67th percentile. All patients undergo elective laparoscopic abdominal surgery under general anesthesia, and postoperative fatigue is assessed on days 1, 3, and 7 using the Christensen fatigue scale and QoR-15 questionnaire.
Medium MAP Variability (MV)
Patients are categorized based on intraoperative mean arterial pressure variability measured by generalized average real variability (G-ARV). The LV group includes patients with G-ARV ≤ 33rd percentile, the MV group includes patients with G-ARV between the 34th and 67th percentile, and the HV group includes patients with G-ARV > 67th percentile. All patients undergo elective laparoscopic abdominal surgery under general anesthesia, and postoperative fatigue is assessed on days 1, 3, and 7 using the Christensen fatigue scale and QoR-15 questionnaire.
High MAP Variability (HV)
Patients are categorized based on intraoperative mean arterial pressure variability measured by generalized average real variability (G-ARV). The LV group includes patients with G-ARV ≤ 33rd percentile, the MV group includes patients with G-ARV between the 34th and 67th percentile, and the HV group includes patients with G-ARV > 67th percentile. All patients undergo elective laparoscopic abdominal surgery under general anesthesia, and postoperative fatigue is assessed on days 1, 3, and 7 using the Christensen fatigue scale and QoR-15 questionnaire.

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
Postoperative Fatigue (Christensen Score)
Time Frame: Postoperative days 1, 3, and 7
Primary outcome is the patient's fatigue level measured using the Christensen fatigue scale on postoperative days 1, 3, and 7. This scale evaluates overall fatigue severity including physical exhaustion, muscle weakness, and attention deficits after laparoscopic abdominal surgery.
Postoperative days 1, 3, and 7

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
Intraoperative Vasoactive Drug Use
Time Frame: During surgery
Total dose of vasoactive drugs administered during surgery
During surgery
Postoperative Recovery Quality (QoR-15 Score)
Time Frame: Postoperative days 1, 3, and 7
Postoperative recovery quality is assessed using the Quality of Recovery-15 (QoR-15) questionnaire on postoperative days 1, 3, and 7. The QoR-15 consists of 15 items, each scored from 0 (worst recovery) to 10 (best recovery). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. Recovery quality can be categorized as excellent (136-150), good (122-135), moderate (90-121), and poor (0-89).
Postoperative days 1, 3, and 7

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.
The First People's Hospital of Lianyungang

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)

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.
April 15, 2026

Primary Completion (Actual)

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.
June 30, 2026

Study Completion (Actual)

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.
June 30, 2026

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).
March 14, 2026

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.
March 14, 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.
March 18, 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.
July 7, 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.
July 3, 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.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-20251111002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings