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

Primary Purpose

Stellate Ganglion Block

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stellate Ganglion Block focused on measuring Delirium, Cognitive Dysfunction, Sleep Disorders

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Affiliated Hospital of Yangzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stellate ganglion block

Control

Arm Description

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

Do nothing

Outcomes

Primary Outcome Measures

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
Changes in the level of actigraphy
Through the actigraphy, monitor the patient's sleep quality
Changes in the level of Pittsburgh sleep quality index
Assess the patient's sleep quality by asking questions on the scale

Secondary Outcome Measures

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
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
Local cerebral Oxygen Saturation
The outcome above should be measured Local cerebral oxygen saturation meter
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
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
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
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
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
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
Changes in the level of S100-β
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

Full Information

First Posted
March 11, 2021
Last Updated
October 21, 2022
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT04800653
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block
Keywords
Delirium, Cognitive Dysfunction, Sleep Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block
Arm Type
Experimental
Arm Description
Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Do nothing
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in the level of Mini-Men-tal State Examination scale score
Description
Assess the cognitive function of the patient by asking questions on the patient scale
Time Frame
The day before surgery and 1,2,3,5,7 days after surgery
Title
Changes in the level of actigraphy
Description
Through the actigraphy, monitor the patient's sleep quality
Time Frame
The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively
Title
Changes in the level of Pittsburgh sleep quality index
Description
Assess the patient's sleep quality by asking questions on the scale
Time Frame
The day before surgery and 1,2,3,5,7 days
Secondary Outcome Measure Information:
Title
Changes in the level of IL-1
Description
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
Time Frame
Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Title
Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)
Description
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
Time Frame
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
Title
Local cerebral Oxygen Saturation
Description
The outcome above should be measured Local cerebral oxygen saturation meter
Time Frame
Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia
Title
Changes in the level of IL-10
Description
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
Time Frame
Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Title
Changes in the level of IL-6
Description
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
Time Frame
Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Title
Changes in the level of Melatonin
Description
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
Time Frame
Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Title
Changes in the level of Heart Rate
Description
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
Time Frame
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
Title
Changes in the level of Oxygen saturation
Description
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
Time Frame
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
Title
Changes in the value and waveform of Narcotrend
Description
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
Time Frame
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
Title
Changes in the level of S100-β
Description
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
Time Frame
Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 years; ASA grade I-III; Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy. Exclusion criteria : Patient's lack of consent to participate; Known allergy to anesthetic drugs; History of psychiatric or neurological disease(s); Long-term use of opioids or sedative-hypnotic drugs; Previous or planned neurosurgical procedures; contraindications to epidural anesthesia; Hearing or visual impairment that precludes scale assessment.
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

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

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