The Effect of Anesthesia Type on Pulmonary Function

December 18, 2018 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

The Effect of General or Spinal Anesthesia on Pulmonary Function Tests in Geriatric Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Tokat, Merkez, Turkey, 60100
        • Gaziosmanpasa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 91 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General Anesthesia
Standard General Anesthesia will be applied.The change of the pulmonary functions will be evaluated via spirometer.
Procedure: General anesthesia
induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)
Diagnostic test: Spirometer
Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)
Active Comparator: Neuraxial Anesthesia
Neuraxial anesthesia will be applied. The change of the pulmonary functions will be evaluated via spirometer.
Diagnostic test: Spirometer
Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)
Procedure: Neuraxial anesthesia
Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes on forced vital capacity
Time Frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Forced vital capacity will be measured via spirometer
At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on forced expiratory volume in 1 s
Time Frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Forced expiratory volume in 1 s will be measured via spirometer
At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on mid-expiratory flow (MEF 25-75)
Time Frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
mid-expiratory flow (MEF 25-75) will be measured via spirometer
At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on peak expiratory flow (PEF)
Time Frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Peak expiratory flow (PEF) will be measured by the spirometer
At Preoperative, postoperative 2. hours, postoperative 24. hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Tuğba Karaman, MD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Actual)

December 2, 2018

Study Completion (Actual)

December 2, 2018

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spiro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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