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Hypercapnia During Shoulder Arthroscopy

NCT ID: NCT02643030

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70ยบ sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Conditions

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Cerebral Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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normocapnia

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

Group Type EXPERIMENTAL

normocapnia

Intervention Type BEHAVIORAL

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

hypercapnia

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

Group Type ACTIVE_COMPARATOR

hypercapnia

Intervention Type BEHAVIORAL

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

Interventions

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hypercapnia

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

Intervention Type BEHAVIORAL

normocapnia

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

Intervention Type BEHAVIORAL

Other Intervention Names

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ETCO2-45 ETCO2-35

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Youn Yi Jo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Cheon Lee, MD

Role: STUDY_CHAIR

Gachon University Gil Medical Center

References

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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.

Reference Type RESULT
PMID: 16171668 (View on PubMed)

Other Identifiers

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GIRBA2674-2012

Identifier Type: -

Identifier Source: org_study_id