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

Stellate Ganglion Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800653
• Other study ID #: 202103101
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: October 2022
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 12, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Ganglion Cysts
• Parasomnias
• Stellate Ganglion Block

Intervention

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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in the level of S100-ß	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