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NCT07863804

Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy

Sponsor: Li Juan

View on ClinicalTrials.gov

Summary

This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes. About 58 participants will join this study. Key requirements to take part: * Aged 18 to 65 years old * Scheduled for laparoscopic gallbladder removal under general anesthesia * Able to give informed consent and finish all study tasks * Can tolerate repeated blood draws * No long-term sleep-affecting medicine use in the past one month * Major organs work normally People cannot join if they: * Are younger than 18 years or older than 65 years * Are pregnant or breastfeeding * Have mental health or cognitive conditions that stop study participation * Have problems that make repeated blood collection unsafe * Have severe organ diseases or recent major injury or surgery * Have alcohol or drug dependence What happens for each participant: 1. Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels. 2. On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated. 3. First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights. Researchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants. Possible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed. Possible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.

Official title: A Prospective Observational Study of Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-09-20

Completion Date

2026-12-30

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Sleep and Circadian Problems

Interventions

OTHER

No study intervention

This is a retrospective observational study based on existing medical records. No intervention, treatment, or procedure is assigned or administered by the study investigators. All data are collected retrospectively from routine clinical care.

Inclusion Criteria: 1. Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements. 2. Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia. 3. No history of severe needle or blood phobia, and able to tolerate repeated venous blood sampling during the perioperative period. 4. No long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids within the past month, except for short-term use for acute illness for no more than 3 days; no other interventions that may affect sleep, such as transcranial magnetic stimulation or cognitive behavioral therapy. 5. Stable vital signs, essentially normal function of major organs, including the heart, brain, lungs, liver, and kidneys, and no severe organic disease; able to tolerate surgery and the study procedures. 6. Able to strictly follow the required sleep-wake schedule during the study period and cooperate with completion of sleep diaries, questionnaires, and all assessments, with good compliance. Exclusion Criteria: * 1: Aged \<18 years or \>65 years; pregnant or breastfeeding women; patients with psychiatric disorders, such as schizophrenia, mania, or depression, cognitive impairment, or inability to cooperate with the study, in order to avoid missing data or study bias due to poor cooperation. 2: Severe coagulation disorders, skin infection at the puncture site, or other conditions unsuitable for repeated blood sampling, to ensure the safety of blood collection procedures. 3: Use of sedative-hypnotics, anxiolytics, antidepressants, hormonal medications, or other sleep-related interventions within the past month that may affect the study outcomes, in order to minimize confounding factors and ensure the accuracy of the results. 4: Severe cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, severe respiratory disease, or other conditions that may affect perioperative recovery or sleep assessment. 5: Major surgery or severe trauma within the past 3 months that may interfere with the perioperative stress response. 6: Alcohol or drug dependence, or consumption of more than three cups of coffee, strong tea, or other stimulant beverages per day with an inability to maintain relatively stable consumption habits during the study period, as substances such as caffeine may interfere with sleep. 7: Voluntary withdrawal from the study before completion, or inability to complete the study due to adverse reactions, poor compliance, or other reasons.