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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stellate Ganglion Block

Intervention / Treatment
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* Procedure: Stellate ganglion block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate ganglion block<br>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<br>* 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<br>|
| No Intervention: Control<br>Do nothing | |

What is the study measuring?
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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 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 | 
| 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 | 
| 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Cognitive Dysfunction, Sleep Disorders