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Completed

NCT Number: NCT05457387

Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

The investigators are performing this research study to understand the role of sleep disturbance on the incidence of delirium after surgery.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

Sleep is one of the most important physiological needs. Sleep disturbances have detri-mental effects on practically all systems and may thus prolong recovery of patients. Studies have documented many similarities between clinical and physiological profiles of patients with delirium and sleep disturbances (ischemia/inflammation, hypoxia, neu-rotransmitter imbalance and tryptophan/melatonin metabolism abnormalities). There is still a lack of strong evidence to support the link between poor sleep and delirium, par-ticularly in hospitalized patients, even though available studies suggest that sleep dis-turbances may be a potential key risk factor for its development, which may have a significant clinical impact.

Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.

The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.

The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Geriatric surgical patients ≥65 years old

Exclusion criteria

Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 7 days post surgery

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  2. the incidence of survival rate

    Time frame: 1 year

    collection of clinical data in the medical record and follow-up update

  3. Sleep NRS

    Time frame: 1 day before the surgery

    sleep numerical rating scale

  4. Sleep NRS

    Time frame: 7 days post surgery

    sleep numerical rating scale

  5. Sleep NRS

    Time frame: baseline

    sleep numerical rating scale

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Tiantan Hospital
  • China-Japan Friendship Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • Fudan University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Sun Yat-sen University
  • Taihe Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital of Central South University
  • Zhejiang Provincial People's Hospital
  • Zhejiang University

Registry information

Official study title

Examining the Association Between Perioperative Sleep Disturbance and Postoperative Delirium During Non-cardiac Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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