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NCT02643030 Clinical Trial

Hypercapnia During Shoulder Arthroscopy

Cerebral Ischemia Clinical Trial

Official title:
The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02643030
Other study ID # GIRBA2674-2012
Secondary ID
Status Completed
Phase N/A
First received December 23, 2015
Last updated December 28, 2015
Start date March 2012
Est. completion date October 2015

Study information
Verified date December 2015
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

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).

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• hypercapnia
Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
• normocapnia
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Regional cerebral oxygen saturation Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position Yes
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