Postoperative DeliriumNCT05847296
Effect of Preoperative Sarcopenia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
An observational study of Postoperative Delirium and Sarcopenia, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The goal of this observational study is to compare Incidence of postoperative delirium in Sarcopenic and non-sarcopenic elderly patients undergoing gastrointestinal surgery. The main question it aims to answer are: Effect of preoperative sarcopenia on postoperative delirium in elderly patients undergoing… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Sarcopenia, Gastrointestinal Surgery
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 1 Feb 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients who come to the Second Affiliated Hospital of Nanchang University for treatment
Who may be able to join
- Age ≥ 65 years old, gender is not limited
- Patients to undergo elective abdominal surgery (gastrointestinal tumor resection) under general anesthesia, with an expected operation duration of about 2h~4h
- ASA Ⅰ-Ⅲ
Who cannot join
- Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications
- Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN
- People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment
- Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack
- Myasthenia gravis patients
- Unable to cooperate to complete the test, the patient or family member rejected the participant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi
Fuzhou Hua, professor, +8615170238929, huafuzhou@126.com
About this study
Official title: The Second Affiliated Hospital of Nanchang University
The goal of this observational study is to compare Incidence of postoperative delirium in Sarcopenic and non-sarcopenic elderly patients undergoing gastrointestinal surgery. The main question it aims to answer are:
- Effect of preoperative sarcopenia on postoperative delirium in elderly patients undergoing gastrointestinal surgery Participants will be evaluated preoperatively for sarcopenia and assessed for postoperative delirium, pain, etc.
- Keywords
- Postoperative Delirium, Sarcopenia, Gastrointestinal surgery, Anesthesia
- Medical subject headings
- Emergence Delirium, Sarcopenia
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 |
|---|---|---|
| Sarcopenia group | Not described | |
| Non sarcopenic group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Postoperative delirium was assessed using the 3D-CAM scale. It consists of 4 features, and a positive feature 1 and 2 plus 3 or 4 is considered postoperative delirium.
Measured: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.
Secondary outcomes (11)
Systolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: Up to 5 hours in the operating room
Diastolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: Up to 5 hours in the operating room
Mean pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: Up to 5 hours in the operating room
Heart rate
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: Up to 5 hours in the operating room
Incidence of postoperative admission to ICU
Including immediate postoperative admission to ICU and postoperative admission to ICU in the ward.
Measured: Up to 1 month after surgery
Length of stay in ICU
Duration of stay in ICU after surgery
Measured: Up to 1 month after surgery
Postoperative pain
The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10
Measured: Within 7 days after surgery
Maximum postoperative C-reactive protein (CRP)
Only the highest CRP values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Measured: Up to 1 month after surgery
Minimum postoperative albumin
Only the lowest albumin values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Measured: Up to 1 month after surgery
Length of hospitalization
The total number of days the patient spent at the hospital for the current consultation
Measured: After the patient is discharged from the hospital, average 1 month
Complication
All the perioperative complications are recorded
Measured: During the perioperative period, up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 May 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- 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
- 334 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847296
- Sponsor's protocol ID
- 2023-OB-01
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 9 May 2023
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Nanchang University
- ClinicalTrials.gov ID
- NCT05847296
- Acronym / sponsor ID
- 2023-OB-01
- Keywords
- Postoperative Delirium, Sarcopenia, Gastrointestinal surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 May 2023 (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.
The goal of this observational study is to compare Incidence of postoperative delirium in Sarcopenic and non-sarcopenic elderly patients undergoing gastrointestinal surgery. The main question it aims to answer are:
- Effect of preoperative sarcopenia on postoperative delirium in elderly patients undergoing gastrointestinal surgery Participants will be evaluated preoperatively for sarcopenia and assessed for postoperative delirium, pain, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia group | – | – |
| Non sarcopenic group | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients who come to the Second Affiliated Hospital of Nanchang University for treatment
Key inclusion criteria (3 listed)
- Age ≥ 65 years old, gender is not limited
- Patients to undergo elective abdominal surgery (gastrointestinal tumor resection) under general anesthesia, with an expected operation duration of about 2h~4h
- ASA Ⅰ-Ⅲ
Key exclusion criteria (6 listed)
- Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications
- Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN
- People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment
- Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack
- Myasthenia gravis patients
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
Incidence of postoperative delirium
Time frame: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.
Postoperative delirium was assessed using the 3D-CAM scale. It consists of 4 features, and a positive feature 1 and 2 plus 3 or 4 is considered postoperative delirium.
11 secondary outcomes
Systolic pressure
Time frame: Up to 5 hours in the operating room
Diastolic pressure
Time frame: Up to 5 hours in the operating room
Mean pressure
Time frame: Up to 5 hours in the operating room
Heart rate
Time frame: Up to 5 hours in the operating room
Incidence of postoperative admission to ICU
Time frame: Up to 1 month after surgery
Length of stay in ICU
Time frame: Up to 1 month after surgery
Postoperative pain
Time frame: Within 7 days after surgery
Maximum postoperative C-reactive protein (CRP)
Time frame: Up to 1 month after surgery
Minimum postoperative albumin
Time frame: Up to 1 month after surgery
Length of hospitalization
Time frame: After the patient is discharged from the hospital, average 1 month
Complication
Time frame: During the perioperative period, up to 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
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 Postoperative Delirium and Sarcopenia, run by Second Affiliated Hospital of Nanchang University 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 6 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua (+8615170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.). 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 9 May 2023.