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Completed

NCT Number: NCT04800653

The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients

Postoperative delirium is an acute state of confusion, which is characterized by changes in attention and cognitive functions and fluctuations in consciousness; postoperative cognitive dysfunction is a common central nervous system complication in elderly patients after surgery, often manifested as memory, Obstacles in abstract thinking and orientation are accompanied by a decline in social activity ability. Postoperative delirium and cognitive dysfunction can prolong hospital stay, increase medical expenses, affect postoperative functional recovery, and even increase postoperative mortality. Sleep disorders are a group of diseases that affect the ability to sleep well regularly and cause severe impairment of social and occupational functions. Stellate ganglion block is a selective sympathetic ganglion block, in which a local anesthetic is injected into the loose connective tissue of the neck including the stellate ganglion. There are complex connections between stellate ganglia and multiple brain regions in the brain, which can improve postoperative delirium, cognitive function and sleep disturbance to a certain extent, and have certain guiding significance for postoperative rehabilitation of elderly patients.

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Key information

Conditions

Stellate Ganglion Block Cognition Disorders Cognitive Dysfunction Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 60 years;
  • ASA grade I-III;
  • Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.

Exclusion criteria

  • Patient's lack of consent to participate;
  • Known allergy to anesthetic drugs;
  • History of psychiatric or neurological disease(s);
  • Long-term use of opioids or sedative-hypnotic drugs;
  • Previous or planned neurosurgical procedures;
  • contraindications to epidural anesthesia;
  • Hearing or visual impairment that precludes scale assessment.

Treatment and study plan

Stellate ganglion block

Procedure

Find the position of the stellate ganglion under ultrasound guidance, and inject 0.375% ropivacaine near the stellate ganglion to block the sympathetic nerves in the upper chest and head and neck

Primary outcomes

  1. Changes in the level of Mini-Men-tal State Examination scale score

    Time frame: The day before surgery and 1,2,3,5,7 days after surgery

    Assess the cognitive function of the patient by asking questions on the patient scale

  2. Changes in the level of actigraphy

    Time frame: The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively

    Through the actigraphy, monitor the patient's sleep quality

  3. Changes in the level of Pittsburgh sleep quality index

    Time frame: The day before surgery and 1,2,3,5,7 days

    Assess the patient's sleep quality by asking questions on the scale

Secondary outcomes

  1. Changes in the level of IL-1

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  2. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  3. Local cerebral Oxygen Saturation

    Time frame: Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia

    The outcome above should be measured Local cerebral oxygen saturation meter

  4. Changes in the level of IL-10

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  5. Changes in the level of IL-6

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  6. Changes in the level of Melatonin

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  7. Changes in the level of Heart Rate

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  8. Changes in the level of Oxygen saturation

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  9. Changes in the value and waveform of Narcotrend

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  10. Changes in the level of S100-β

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Oct 24, 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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