Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests

March 10, 2016 updated by: Abdulvahap Oguz, Istanbul University

Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests in Patients Undergoing Endoscopic Endonasal Transsphenoidal Surgery of Pituitary Gland

This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.

Study Type

Interventional

Enrollment (Anticipated)

90

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
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department
        • Contact:
        • Sub-Investigator:
          • Eren F Akcıl, M.D.
        • Sub-Investigator:
          • Yusuf Tunalı, Prof.

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) score I-II patients

Exclusion Criteria:

  • Significant cardiopulmonary disease,
  • Diagnosed obstructive or restrictive pulmonary disease,
  • Patients with chest wall deformities, liver or kidney failure,
  • Postoperative lack of cooperation

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation
Drug: Sevoflurane
1-1.5 MAC, inhalation route, during operation
Other Names:
  • Sevorane
Active Comparator: Desflurane
1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation
Drug: Desflurane
1-1.5 MAC, inhalation route, during operation
Other Names:
  • Suprane
Active Comparator: Propofol
6-10 mg/kg/h, iv infusion, during operation
Drug: Propofol
6-10 mg/kg/h, iv infusion, during operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline FEV1%predicted (no unit)
Time Frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
FEV1 is measured with spirolab III colour liquid-crystal-display medical spirometer. FEV1%predicted is calculated with age, sex, height and weight input by the same equipment.
Preoperative baseline, postoperative 1st hour and postoperative 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline FVC%predicted (no unit)
Time Frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
FVC is measured with spirolab III colour liquid-crystal-display medical spirometer. FVC%predicted is calculated with age, sex, height and weight input by the same equipment.
Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline FEV1/FVC ratio (no units)
Time Frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
FEV1/FVC ratio is calculated by spirolab III colour liquid-crystal-display medical spirometer based on age, sex, height and weight.
Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2 (mmHg)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
PaO2 is a component of arterial blood gas analysis done with Cobas B221.
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaCO2 (mmHg)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
PaCO2 is a component of arterial blood gas analysis done with Cobas B221.
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline pH
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
pH is a component of arterial blood gas analysis done with Cobas B221
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline SaO2 (%)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
SaO2 is a component of arterial blood gas analysis done with Cobas B221
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline BE (mmol/L)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
BE is a component of arterial blood gas analysis done with Cobas B221
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline HCO3 (mmol/L)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
HCO3 is a component of arterial blood gas analysis done with Cobas B221
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2/FiO2 ratio (no units)
Time Frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
PaO2/FiO2 ratio is calculated by investigators
Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Study Director: Özlem Korkmaz Dilmen, Assoc. Prof., Istanbul University

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

October 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83045809/604.01/02 (Other Identifier: Ethical Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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