- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481006
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zhang
- Phone Number: 18961322507
- Email: hotdog100@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years;
- ASA physical status I-III;
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia.
Exclusion Criteria:
- 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.
Study Plan
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-20251111002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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