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

NCT04800653 | Completed

• 1 other identifier: 202103101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stellate Ganglion Block

Keywords

Delirium; Cognitive Dysfunction; Sleep Disorders

Outcome Measures

Primary Outcomes (3)

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

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

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

• Changes in the level of actigraphy

  Through the actigraphy, monitor the patient's sleep quality

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

• Changes in the level of Pittsburgh sleep quality index

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

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

Secondary Outcomes (10)

• Changes in the level of IL-1

  Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

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

  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

• Local cerebral Oxygen Saturation

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

• Changes in the level of IL-10

  Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

• Changes in the level of IL-6

  Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

Study Arms (2)

Stellate ganglion block

EXPERIMENTAL

Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.

Procedure: Stellate ganglion block

Control

NO INTERVENTION

Do nothing

Interventions

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

Stellate ganglion block

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

Related Publications (1)

• Yan S, Wang Y, Yu L, Xia W, Xue F, Yu Y, Yuan B, Li N, Li H, Liang H, Ma J, Zhang Z. Stellate ganglion block alleviates postoperative sleep disturbance in patients undergoing radical surgery for gastrointestinal malignancies. J Clin Sleep Med. 2023 Sep 1;19(9):1633-1642. doi: 10.5664/jcsm.10632.

  PMID: 37128727 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 12, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CN (1)