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

Sponsor

Yangzhou University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800653

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stellate Ganglion Block	Procedure: Stellate ganglion block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stellate ganglion block Before the operation, the right 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

Arm

Intervention/Treatment

Experimental: Stellate ganglion block

Before the operation, the right 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

Outcome Measures

Primary Outcome Measures

Changes in the level of CAM-ICU scale score [1,2,3,7 days after surgery]
First, evaluate the patient's state of consciousness based on the patient's behavior, and decide whether to proceed with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.
Changes in the level of Delirium Rating Scale,(DRS-R-98) scale score [1,2,3,7 days after surgery]
Use the questions on the scale to assess the patient's degree of delirium
Changes in the level of Mini-Men-tal State Examination scale score [The day before surgery and 1,2,3,7 days after surgery]
Assess the cognitive function of the patient by asking questions on the patient scale
Changes in the level of Polysomnography [Baseline , after induction of general anesthesia, immediately before intubation, during intubation, immediately after intubation, at the beginning of surgery, 1 hour after surgery, end of surgery, immediately before extubation, during extubation, 5min]
Through the polysomnograph, monitor the patient's sleep during anesthesia, including brain wave changes and sleep stages at different time points
Changes in the level of Pittsburgh sleep quality index [The day before surgery and 1,2,3,7 days and 1,2,3,4 weeksafter surgery]
Assess the patient's sleep quality by asking questions on the scale

Secondary Outcome Measures

Changes in the level of White blood cell count [Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery]
The outcome above should be measured at the time Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh 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]
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
Local cerebral Oxygen Saturation [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
Changes in the level of Neutrophils [Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery]
The outcome above should be measured at the time Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery
Changes in the level of C-reactive protein [Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery]
The outcome above should be measured at the time Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery
Changes in the level of IL-6 [Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery]
The outcome above should be measured at the time Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery
Changes in the level of Melatonin [Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery]
The outcome above should be measured at the time Preoperative, 1 hour after surgery, 6 am and 12 am on the first day after surgery, 6 am and 12 am on the second day after surgery, 6 am and 12 am on the seventh day after surgery
Changes in the level of Heart Rate [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
Changes in the level of Oxygen saturation [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
Changes in the value and waveform of Narcotrend [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women are not limited, age ≥60 years old, ASA classification I-III, postoperative hospital stay no less than 7 days, operation time ≥2h, and have the ability to listen, speak, read, write and comprehend to complete the cognitive scale.

Exclusion Criteria:

Patients with preoperative MMSE score less than 24 points or dementia due to various reasons; (2) Patients planning to undergo neurosurgery; (3) Patients taking sedatives or antipsychotics daily and drinking a lot of alcohol; (4) ) Patients with known central nervous system diseases, such as psychiatric patients; (5) Patients whose hearing or vision impairments prevent neuropsychological testing (6) Diagnosed with cerebrovascular diseases (such as stroke, carotid atherosclerotic stenosis or transient Ischemic attack) (7) emergency surgery; (8) patients using penehyclidine hydrochloride/atropine.