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.

Study Overview

• Status: Completed
• Conditions: Stellate Ganglion Block
• Intervention / Treatment: Procedure: Stellate ganglion block

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • The Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stellate ganglion block; 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; 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
NO_INTERVENTION: Control; Do nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)	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	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
Changes in the level of Heart Rate	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	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
Changes in the level of Oxygen saturation	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	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
Changes in the level of IL-1	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	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Local cerebral Oxygen Saturation	The outcome above should be measured Local cerebral oxygen saturation meter	Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia
Changes in the level of IL-10	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	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the level of IL-6	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	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the level of Melatonin	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	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the value and waveform of Narcotrend	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	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
Changes in the level of S100-β	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	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): July 12, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 13, 2021
• First Posted (ACTUAL): March 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Sleep Disorders; Cognitive Dysfunction; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms; Sleep Wake Disorders; Cysts; Connective Tissue Diseases; Mucinoses; Dyssomnias; Parasomnias; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: 202103101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No