Clinical trial NCT04800653: The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
Official title: The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stellate Ganglion Block
Keywords: Delirium
Cognitive Dysfunction
Sleep Disorders
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the level of Mini-Men-tal State Examination scale score
timeFrame: The day before surgery and 1,2,3,5,7 days after surgery
measure: Changes in the level of actigraphy
timeFrame: The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively
measure: Changes in the level of Pittsburgh sleep quality index
timeFrame: The day before surgery and 1,2,3,5,7 days
Secondary outcomes:
measure: Changes in the level of IL-1
timeFrame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
measure: Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)
timeFrame: 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
measure: Local cerebral Oxygen Saturation
timeFrame: Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia
measure: Changes in the level of IL-10
timeFrame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
measure: Changes in the level of IL-6
timeFrame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
measure: Changes in the level of Melatonin
timeFrame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
measure: Changes in the level of Heart Rate
timeFrame: 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
measure: Changes in the level of Oxygen saturation
timeFrame: 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
measure: Changes in the value and waveform of Narcotrend
timeFrame: 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
measure: Changes in the level of S100-β
timeFrame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
References: