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The Effect of Anesthesia Type on Pulmonary Function

NCT ID: NCT03399201

Last Updated: 2018-12-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2018-12-02

Brief Summary

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The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery.

Detailed Description

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Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary function tests will be evaluated.

Conditions

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Anesthesia Geriatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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General Anesthesia

Standard General Anesthesia will be applied.The change of the pulmonary functions will be evaluated via spirometer.

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)

Spirometer

Intervention Type DIAGNOSTIC_TEST

Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)

Neuraxial Anesthesia

Neuraxial anesthesia will be applied. The change of the pulmonary functions will be evaluated via spirometer.

Group Type ACTIVE_COMPARATOR

Neuraxial anesthesia

Intervention Type PROCEDURE

Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).

Spirometer

Intervention Type DIAGNOSTIC_TEST

Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)

Interventions

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General anesthesia

induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)

Intervention Type PROCEDURE

Neuraxial anesthesia

Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).

Intervention Type PROCEDURE

Spirometer

Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 65 years of age
* Undergoing non-abdominal surgery under anesthesia in supine position

Exclusion Criteria

* Pulmonary disease
* Hematological disease
* Undergoing Abdominal surgery
* Non-supine position during surgery
* Nicotine Abuse
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Karaman

Associate Professor,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuğba Karaman, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Gaziosmanpasa University Hospital

Tokat Province, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Spiro

Identifier Type: -

Identifier Source: org_study_id