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

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

353

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

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

  • 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
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

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

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.

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 (Estimated)

April 15, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID 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.

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