Stellate Ganglion BlockNCT04800653
The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
A study testing Stellate ganglion block in people with Stellate Ganglion Block, run by Yangzhou University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 60 years;
- ASA grade I-III;
- Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stellate Ganglion Block
- Being tested
- Stellate ganglion block
- Keywords
- Delirium, Cognitive Dysfunction, Sleep Disorders
- Medical subject headings
- Delirium, Cognitive Dysfunction, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block | Experimental | Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion. Receives: Procedure: Stellate ganglion block |
| Control | No intervention | Do nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The day before surgery and 1,2,3,5,7 days after surgery
Changes in the level of actigraphy
Through the actigraphy, monitor the patient's sleep quality
Measured: The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively
Changes in the level of Pittsburgh sleep quality index
Assess the patient's sleep quality by asking questions on the scale
Measured: The day before surgery and 1,2,3,5,7 days
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Local cerebral Oxygen Saturation
The outcome above should be measured Local cerebral oxygen saturation meter
Measured: Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800653
- Sponsor's protocol ID
- 202103101
- Status last verified
- Oct 2022
- First submitted
- 11 Mar 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan S, Wang Y, Yu L, Xia W, Xue F, Yu Y, Yuan B, Li N, Li H, Liang H, Ma J, Zhang Z. Stellate ganglion block alleviates postoperative sleep disturbance in patients undergoing radical surgery for gastrointestinal malignancies. J Clin Sleep Med. 2023 Sep 1;19(9):1633-1642. doi: 10.5664/jcsm.10632.
PubMed 37128727
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
- ClinicalTrials.gov ID
- NCT04800653
- Acronym / sponsor ID
- 202103101
- Conditions
- Stellate Ganglion Block
- Keywords
- Delirium, Cognitive Dysfunction, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block | Experimental | Procedure: Stellate ganglion blockBefore the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion. |
| Control | No intervention | –Do nothing |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years;
- ASA grade I-III;
- Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate ganglion blockFind 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 | Procedure or surgery | Stellate ganglion block |
Primary outcome
Changes in the level of Mini-Men-tal State Examination scale score
Time frame: 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 actigraphy
Time frame: 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 Pittsburgh sleep quality index
Time frame: The day before surgery and 1,2,3,5,7 days
Assess the patient's sleep quality by asking questions on the scale
10 secondary outcomes
Changes in the level of IL-1
Time frame: 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)
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
Local cerebral Oxygen Saturation
Time frame: Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia
Changes in the level of IL-10
Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the level of IL-6
Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the level of Melatonin
Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Changes in the level of Heart Rate
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
Changes in the level of Oxygen saturation
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
Changes in the value and waveform of Narcotrend
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
Changes in the level of S100-β
Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 37128727Yan S, Wang Y, Yu L, Xia W, Xue F, Yu Y, Yuan B, Li N, Li H, Liang H, Ma J, Zhang Z. Stellate ganglion block alleviates postoperative sleep disturbance in patients undergoing radical surgery for gastrointestinal malignancies. J Clin Sleep Med. 2023 Sep 1;19(9):1633-1642. doi: 10.5664/jcsm.10632.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Stellate Ganglion Block, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of Mini-Men-tal State Examination scale score (time frame: The day before surgery and 1,2,3,5,7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.