Postoperative DeliriumNCT07042503
Effects of Different Preoperative Oral Rehydration Protocols in Undergoing Thoracoscopic Radical Lung Cancer Surgery
An observational study of Postoperative Delirium, run by Fujian Medical University Union Hospital.
Trial summary
This study aims to compare the new preoperative oral rehydration protocol (administering 50-100 mL of clear fluids or carbohydrate-rich beverages orally every hour until the patient arrives at the operating room) with the traditional preoperative protocol (consuming 200-300 mL of water orally two hours prior to… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Postoperative Delirium
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2026
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly patients undergoing thoracoscopic lung cancer radical surgery
Who may be able to join
- Elderly patients aged 65 or above who are scheduled to undergo thoracoscopic radical lung cancer surgery.
- American Society of Anesthesiologists (ASA) classification levels II-III.
- No severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≥ 24).
- Able to cooperate with the study and sign the informed consent form.
Who cannot join
- Combined with severe functional impairments of important organs such as the heart, liver, and kidneys.
- Suffering from metabolic diseases such as diabetes and hyperthyroidism.
- Having digestive system diseases such as gastric emptying disorders, dysphagia, and intestinal obstruction.
- Allergic or intolerant to carbohydrates.
- Had received treatments such as radiotherapy and chemotherapy before the surgery that might affect the research indicators.
- Patients with mental disorders or cognitive dysfunction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Different Preoperative Oral Rehydration Protocols on Safety, Comfort, and Postoperative Outcomes in Elderly Patients Undergoing Thoracoscopic Radical Lung Cancer Surgery: A Randomized Controlled Trial
This study aims to compare the new preoperative oral rehydration protocol (administering 50-100 mL of clear fluids or carbohydrate-rich beverages orally every hour until the patient arrives at the operating room) with the traditional preoperative protocol (consuming 200-300 mL of water orally two hours prior to surgery). The objective is to investigate the effects of these two protocols on the safety (e.g., risk of reflux and aspiration), comfort (e.g., levels of hunger, thirst, and anxiety), gastric emptying status (as assessed by gastric ultrasound indicators), and postoperative outcomes (e.g., incidence of postoperative delirium, insulin resistance, and inflammatory factor levels) in elderly patients undergoing thoracoscopic lung cancer radical surgery. This research seeks to identify a more appropriate preoperative rehydration protocol for elderly lung cancer patients.
Read the detailed description
This study employed a randomized controlled double-blind trial, including 420 elderly patients (aged 65 and above) who were scheduled to undergo thoracoscopic lung cancer radical surgery. The efficacy of three preoperative oral rehydration regimens was compared. The control group orally consumed 200-300ml of clear water 2 hours before the operation; the intervention group 1 orally consumed 50-100ml of clear water every hour before the operation; the intervention group 2 orally consumed 50-100ml of 12.5% carbohydrate beverages every hour before the operation, all requiring to be consumed slowly within 10-15 minutes. The evaluation indicators included: safety (intraoperative reflux aspiration, postoperative nausea and vomiting, incision and pulmonary infection rates), gastric ultrasound (amount of fluid in the stomach and emptying time), comfort (VAS for assessing hunger and thirst, SAS for assessing anxiety), postoperative delirium (CAM scale combined with electroencephalogram), insulin resistance (FPG, FINS, and HOMA-IR), and inflammatory factors (Interleukin-6, Tumor necrosis factor -α, C-reactive protein). The research data were analyzed using SPSS software to clarify the impact of different rehydration regimens on elderly patients.
- Conditions
- Postoperative Delirium
- Keywords
- preoperative oral rehydration protocol, Postoperative delirium, insulin resistance, gastric emptying status, preoperative anxiety
- Medical subject headings
- Emergence Delirium, Insulin Resistance
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 |
|---|---|---|
| Control Arm | 2-hour Preoperative Ingestion of 200-300 mL clear water | |
| Intervention Arm 1 | Hourly Preoperative Ingestion of 50-100 mL clear water | |
| Intervention Arm 2 | Hourly Preoperative Ingestion of 50-100 mL 12.5% carbohydrate-containing beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
The Confusion Assessment Method - Short Form(CAM-S) scoring for postoperative delirium is as follows:
Total score 20 points, 0-6 points :Mild delirium; 7-12 points:Moderate delirium;
≥13 points: Severe delirium.
Measured: One to three days after the operation
preoperative anxiety
The Generalized Anxiety Disorder-7 (GAD-7) scale for preoperative anxiety assessment is as follows:Total score: 21 points，0-4 points: Normal，5-9 points: Mild anxiety，10-14 points: Moderate anxiety，≥15 points: Severe anxiety.
Measured: One day before the operation and in the morning of the operation
The amount of fluid in the stomach
Ultrasound examination of the cross-sectional area of the antrum of the stomach
Measured: 2 hours before the operation, 1 hour before the operation, and before anesthesia induction
insulin resistance
venous blood was collected from the patients to detect fasting plasma glucose (FPG), insulin (FINS), and homeostasis model assessment of insulin resistance index (HOMA-IR).
Measured: on the early morning of the day before the operation,the first day and the third day after operation
Secondary outcomes (7)
Perioperative hunger
The Visual Analogue Scale (VAS) allowed patients to rate their feelings of hunger (0-10 points, 0 for no hunger and 10 for extreme hunger) and thirst (0-10 points, 0 for no thirst and 10 for extreme thirst)
Measured: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation
Perioperative thirst
The Visual Analogue Scale (VAS) was used to score the sensation of thirst (on a scale of 0 to 10, where 0 indicates no sensation of thirst and 10 indicates extreme thirst)
Measured: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation
The incidence of reflux aspiration during the perioperative period
Closely observe whether the patient has reflux or aspiration
Measured: During the operation and 3 days after the operation
The incidence of perioperative nausea and vomiting
Record the frequency and severity of nausea and vomiting
Measured: During the operation and 3 days after the operation
C-reactive protein
The fasting venous blood of the patients was collected and detected by immunoturbidimetry.
Measured: on the early morning of the day before the operation,the first day and the third day after operation
Tumor necrosis factor -α
The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).
Measured: on the early morning of the day before the operation,the first day and the third day after operation
Interleukin-6
The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).
Measured: on the early morning of the day before the operation,the first day and the third day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (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 Fujian Medical University Union HospitalThe 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
- 420 participants (estimated)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan Lin, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042503
- Sponsor's protocol ID
- fish77033
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The way of sharing IPD：ResMan, http://www.medresman.org.cn/login.aspx
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Preoperative Oral Rehydration Protocols on Safety, Comfort, and Postoperative Outcomes in Elderly Patients Undergoing Thoracoscopic Radical Lung Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07042503
- Acronym / sponsor ID
- fish77033
- Conditions
- Postoperative Delirium
- Keywords
- preoperative oral rehydration protocol, Postoperative delirium, insulin resistance, gastric emptying status, preoperative anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Jun 2025 (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 study aims to compare the new preoperative oral rehydration protocol (administering 50-100 mL of clear fluids or carbohydrate-rich beverages orally every hour until the patient arrives at the operating room) with the traditional preoperative protocol (consuming 200-300 mL of water orally two hours prior to surgery). The objective is to investigate the effects of these two protocols on the safety (e.g., risk of reflux and aspiration), comfort (e.g., levels of hunger, thirst, and anxiety), gastric emptying status (as assessed by gastric ultrasound indicators), and postoperative outcomes (e.g., incidence of postoperative delirium, insulin resistance, and inflammatory factor levels) in elderly patients undergoing thoracoscopic lung cancer radical surgery. This research seeks to identify a more appropriate preoperative rehydration protocol for elderly lung cancer patients.
Detailed description
This study employed a randomized controlled double-blind trial, including 420 elderly patients (aged 65 and above) who were scheduled to undergo thoracoscopic lung cancer radical surgery. The efficacy of three preoperative oral rehydration regimens was compared. The control group orally consumed 200-300ml of clear water 2 hours before the operation; the intervention group 1 orally consumed 50-100ml of clear water every hour before the operation; the intervention group 2 orally consumed 50-100ml of 12.5% carbohydrate beverages every hour before the operation, all requiring to be consumed slowly within 10-15 minutes. The evaluation indicators included: safety (intraoperative reflux aspiration, postoperative nausea and vomiting, incision and pulmonary infection rates), gastric ultrasound (amount of fluid in the stomach and emptying time), comfort (VAS for assessing hunger and thirst, SAS for assessing anxiety), postoperative delirium (CAM scale combined with electroencephalogram), insulin resistance (FPG, FINS, and HOMA-IR), and inflammatory factors (Interleukin-6, Tumor necrosis factor -α, C-reactive protein). The research data were analyzed using SPSS software to clarify the impact of different rehydration regimens on elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | – | –2-hour Preoperative Ingestion of 200-300 mL clear water |
| Intervention Arm 1 | – | –Hourly Preoperative Ingestion of 50-100 mL clear water |
| Intervention Arm 2 | – | –Hourly Preoperative Ingestion of 50-100 mL 12.5% carbohydrate-containing beverages |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patients undergoing thoracoscopic lung cancer radical surgery
Key inclusion criteria (4 listed)
- Elderly patients aged 65 or above who are scheduled to undergo thoracoscopic radical lung cancer surgery.
- American Society of Anesthesiologists (ASA) classification levels II-III.
- No severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≥ 24).
- Able to cooperate with the study and sign the informed consent form.
Key exclusion criteria (6 listed)
- Combined with severe functional impairments of important organs such as the heart, liver, and kidneys.
- Suffering from metabolic diseases such as diabetes and hyperthyroidism.
- Having digestive system diseases such as gastric emptying disorders, dysphagia, and intestinal obstruction.
- Allergic or intolerant to carbohydrates.
- Had received treatments such as radiotherapy and chemotherapy before the surgery that might affect the research indicators.
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 delirium
Time frame: One to three days after the operation
The Confusion Assessment Method - Short Form(CAM-S) scoring for postoperative delirium is as follows: Total score 20 points, 0-6 points :Mild delirium; 7-12 points:Moderate delirium; ≥13 points: Severe delirium.
preoperative anxiety
Time frame: One day before the operation and in the morning of the operation
The Generalized Anxiety Disorder-7 (GAD-7) scale for preoperative anxiety assessment is as follows:Total score: 21 points，0-4 points: Normal，5-9 points: Mild anxiety，10-14 points: Moderate anxiety，≥15 points: Severe anxiety.
The amount of fluid in the stomach
Time frame: 2 hours before the operation, 1 hour before the operation, and before anesthesia induction
Ultrasound examination of the cross-sectional area of the antrum of the stomach
insulin resistance
Time frame: on the early morning of the day before the operation,the first day and the third day after operation
venous blood was collected from the patients to detect fasting plasma glucose (FPG), insulin (FINS), and homeostasis model assessment of insulin resistance index (HOMA-IR).
7 secondary outcomes
Perioperative hunger
Time frame: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation
Perioperative thirst
Time frame: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation
The incidence of reflux aspiration during the perioperative period
Time frame: During the operation and 3 days after the operation
The incidence of perioperative nausea and vomiting
Time frame: During the operation and 3 days after the operation
C-reactive protein
Time frame: on the early morning of the day before the operation,the first day and the third day after operation
Tumor necrosis factor -α
Time frame: on the early morning of the day before the operation,the first day and the third day after operation
Interleukin-6
Time frame: on the early morning of the day before the operation,the first day and the third day after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided. The way of sharing IPD：ResMan, http://www.medresman.org.cn/login.aspx
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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.
Nan Lin principal investigator
Fujian Medical University Union Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Fujian Medical University Union Hospital.
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 4 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nan Lin (+8618518134145, 117806006@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium (time frame: One to three days after the operation). The study lists 4 primary outcomes in all. 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 29 Jun 2025.