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

NCT ID: NCT04800653

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-07-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Stellate ganglion block

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

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: 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

Control

Do nothing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stellate ganglion block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 60 years;

2. ASA grade I-III;

3. Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.

Exclusion Criteria

1. Patient's lack of consent to participate;

2. Known allergy to anesthetic drugs;

3. History of psychiatric or neurological disease(s);

4. Long-term use of opioids or sedative-hypnotic drugs;

5. Previous or planned neurosurgical procedures;

6. contraindications to epidural anesthesia;

7. Hearing or visual impairment that precludes scale assessment.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37128727 (View on PubMed)

Other Identifiers

202103101

Identifier Type: -

Identifier Source: org_study_id