NCT07481006

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

March 14, 2026

Last Update Submit

July 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Fatigue (Christensen Score)

    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 Outcomes (2)

  • Intraoperative Vasoactive Drug Use

    During surgery

  • Postoperative Recovery Quality (QoR-15 Score)

    Postoperative days 1, 3, and 7

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lianyungang

Lianyungang, 博士, 222061, China

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 18, 2026

Study Start

April 15, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations