Back to resultsSleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.25% ropivacaine hydrochloride
saline
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring bispectral index, regional cerebral oxygen saturation, Stellate-ganglion block
Eligibility Criteria
Inclusion Criteria:
- At least18 years and pre-menopausal;
- scheduled to undergo elective breast cancer operation;
- American Society of Anaesthesiologists (ASA) risk classification I-II.
Exclusion Criteria:
- (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) a history of psychiatric or neurological disease; (5) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.
Sites / Locations
- the First Hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control
stellate-ganglion block
Arm Description
All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline.
All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with 0.25% ropivacaine hydrochloride.
Outcomes
Primary Outcome Measures
sleep quality
The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery.
Secondary Outcome Measures
regional cerebral oxygen saturation
physiological parameter of regional cerebral oxygen saturation of all patients during the operation will be recorded.Regional cerebral oxygen saturation measured by near-infrared spectroscopy in the frontal lobe has been used previously to evaluate overall cerebral blood flow. The normal range of cerebral oxygen saturation is 55-80%.
Full Information
NCT ID
NCT02651519
First Posted
January 5, 2016
Last Updated
March 23, 2017
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02651519
Brief Title
Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
Official Title
Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stellate-ganglion block have been done safely for more than 60 years. It has proved to provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed in the operation.
Detailed Description
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to Stellate-ganglion block with 0.25% ropivacaine hydrochloride or saline. The objective of the trial is to evaluate the postoperative sleep quality of patients undergoing breast cancer operation with Stellate-ganglion block 0.25% ropivacaine hydrochloride or saline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
bispectral index, regional cerebral oxygen saturation, Stellate-ganglion block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline.
Arm Title
stellate-ganglion block
Arm Type
Experimental
Arm Description
All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with 0.25% ropivacaine hydrochloride.
Intervention Type
Drug
Intervention Name(s)
0.25% ropivacaine hydrochloride
Intervention Description
stellate-ganglion block with 0.25% ropivacaine hydrochloride
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
stellate-ganglion block with saline
Primary Outcome Measure Information:
Title
sleep quality
Description
The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery.
Time Frame
first postoperative night
Secondary Outcome Measure Information:
Title
regional cerebral oxygen saturation
Description
physiological parameter of regional cerebral oxygen saturation of all patients during the operation will be recorded.Regional cerebral oxygen saturation measured by near-infrared spectroscopy in the frontal lobe has been used previously to evaluate overall cerebral blood flow. The normal range of cerebral oxygen saturation is 55-80%.
Time Frame
In the operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least18 years and pre-menopausal;
scheduled to undergo elective breast cancer operation;
American Society of Anaesthesiologists (ASA) risk classification I-II.
Exclusion Criteria:
(1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) a history of psychiatric or neurological disease; (5) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-fei Tan, PhD,MD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29043600
Citation
Jin F, Li XQ, Tan WF, Ma H, Fang B, Tian AY, Lu HW. Effects of ultrasound-guided stellate-ganglion block on sleep and regional cerebral oxygen saturation in patients undergoing breast cancer surgery: a randomized, controlled, double-blinded trial. J Clin Monit Comput. 2018 Oct;32(5):855-862. doi: 10.1007/s10877-017-0074-3. Epub 2017 Oct 17.
Results Reference
derived
Learn more about this trial
Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
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