Fatigue SymptomNCT07481006
Association Between Intraoperative Mean Arterial Pressure Variability and Postoperative Fatigue in Patients Undergoing Laparoscopic Abdominal Surgery
An observational study of Fatigue Symptom and Blood Pressure Variability, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Symptom, Blood Pressure Variability
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 30 Jun 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years;
- ASA physical status I-III;
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fatigue Symptom, Blood Pressure Variability
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 1, 3, and 7
Secondary outcomes (2)
Intraoperative Vasoactive Drug Use
Total dose of vasoactive drugs administered during surgery
Measured: During surgery
Postoperative Recovery Quality (QoR-15 Score)
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).
Measured: Postoperative days 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Apr 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481006
- Sponsor's protocol ID
- KY-20251111002
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intraoperative Mean Arterial Pressure Variability and Postoperative Fatigue in Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07481006
- Acronym / sponsor ID
- KY-20251111002
- Conditions
- Fatigue Symptom, Blood Pressure Variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- ASA physical status I-III;
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Intraoperative Vasoactive Drug Use
Time frame: During surgery
Postoperative Recovery Quality (QoR-15 Score)
Time frame: Postoperative days 1, 3, and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Symptom and Blood Pressure Variability, run by The First People's Hospital of Lianyungang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Fatigue (Christensen Score) (time frame: Postoperative days 1, 3, and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.