Hypercapnia During Shoulder Arthroscopy

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

Sponsors

Lead Sponsor: Gachon University Gil Medical Center

Source Gachon University Gil Medical Center
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).

Overall Status Completed
Start Date March 2012
Completion Date October 2015
Primary Completion Date September 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Regional cerebral oxygen saturation Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
Enrollment 40
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: hypercapnia

Description: Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg

Arm Group Label: hypercapnia

Other Name: ETCO2-45

Intervention Type: Behavioral

Intervention Name: normocapnia

Description: Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

Arm Group Label: normocapnia

Other Name: ETCO2-35

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kyung Cheon Lee, MD Study Chair Gachon University Gil Medical Center
Verification Date

December 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Gachon University Gil Medical Center

Investigator Full Name: Youn Yi Jo

Investigator Title: Assistant professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: normocapnia

Type: Experimental

Description: Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

Label: hypercapnia

Type: Active Comparator

Description: Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov