Hypercapnia During Shoulder Arthroscopy
Primary Purpose
Cerebral Ischemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypercapnia
normocapnia
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Ischemia
Eligibility Criteria
Inclusion Criteria:
- patients undergoing elective shoulder arthroscopic surgery
Exclusion Criteria:
- a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
normocapnia
hypercapnia
Arm Description
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Outcomes
Primary Outcome Measures
Regional cerebral oxygen saturation
Secondary Outcome Measures
Full Information
NCT ID
NCT02643030
First Posted
December 23, 2015
Last Updated
December 28, 2015
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02643030
Brief Title
Hypercapnia During Shoulder Arthroscopy
Official Title
The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.
Detailed Description
The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normocapnia
Arm Type
Experimental
Arm Description
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Arm Title
hypercapnia
Arm Type
Active Comparator
Arm Description
Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Intervention Type
Behavioral
Intervention Name(s)
hypercapnia
Other Intervention Name(s)
ETCO2-45
Intervention Description
Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Intervention Type
Behavioral
Intervention Name(s)
normocapnia
Other Intervention Name(s)
ETCO2-35
Intervention Description
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Primary Outcome Measure Information:
Title
Regional cerebral oxygen saturation
Time Frame
Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing elective shoulder arthroscopic surgery
Exclusion Criteria:
a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee, MD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16171668
Citation
Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
Results Reference
result
Learn more about this trial
Hypercapnia During Shoulder Arthroscopy
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