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

Not Applicable

Completed

• Conditions: Stellate Ganglion Block
• Interventions: Procedure: Stellate ganglion block

• Registration Number: NCT04800653
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-13
• Study First Posted: 2021-03-16
• Primary Completion: 2022-03-01
• Study Completion: 2022-07-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in the level of actigraphy	The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively	Through the actigraphy, monitor the patient's sleep quality
Changes in the level of Mini-Men-tal State Examination scale score	The day before surgery and 1,2,3,5,7 days after surgery	Assess the cognitive function of the patient by asking questions on the patient scale
Changes in the level of Pittsburgh sleep quality index	The day before surgery and 1,2,3,5,7 days	Assess the patient's sleep quality by asking questions on the scale

Secondary Outcome Measures

Name	Time	Method
Changes in the level of IL-6	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery	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
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 level of IL-1	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery	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
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
Changes in the level of Melatonin	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery	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
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 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 IL-10	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery	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
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
Changes in the level of S100-β	Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery	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

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China