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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04800653
Enrollment
48
Registered
2021-03-16
Start date
2021-03-01
Completion date
2022-07-12
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stellate Ganglion Block

Keywords

Delirium, Cognitive Dysfunction, Sleep Disorders

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.

Interventions

PROCEDUREStellate 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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the level of Mini-Men-tal State Examination scale scoreThe day before surgery and 1,2,3,5,7 days after surgeryAssess the cognitive function of the patient by asking questions on the patient scale
Changes in the level of actigraphyThe 1st night before the operation and the 1st, 2nd and 3rd nights postoperativelyThrough the actigraphy, monitor the patient's sleep quality
Changes in the level of Pittsburgh sleep quality indexThe day before surgery and 1,2,3,5,7 daysAssess the patient's sleep quality by asking questions on the scale

Secondary

MeasureTime frameDescription
Changes in the level of IL-10Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgeryThe 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 IL-6Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgeryThe 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 MelatoninPreoperative, 6 am on the first day after surgery, 6 am on the third day after surgeryThe 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 IL-1Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgeryThe 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 saturationBaseline (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 operationThe 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 NarcotrendBaseline (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 operationThe 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-βPreoperative, 6 am on the first day after surgery, 6 am on the third day after surgeryThe 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 Heart RateBaseline (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 operationThe 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 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 operationThe 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 SaturationCollected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesiaThe outcome above should be measured Local cerebral oxygen saturation meter

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026