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Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

Primary Purpose

Oxygen Saturation

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oxygen Saturation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in American Society of Anesthesiology (ASA) classification I and II
  • Patients undergoing elective septoplasty operation

Exclusion Criteria:

  • Patients in ASA classification III and higher
  • Emergency surgery
  • Patients in New York Heart Association classification III-IV
  • Patients with known allergy to drugs used in the study

Sites / Locations

  • Ufuk University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sevoflurane

Desflurane

Arm Description

Outcomes

Primary Outcome Measures

Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
The effect of sevoflurane and desflurane on NIRS values

Secondary Outcome Measures

Total remifentanil consumption as measured in micrograms
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on mean arterial pressure
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on heart rate
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on bispectral index

Full Information

First Posted
June 24, 2016
Last Updated
August 18, 2020
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT02834845
Brief Title
Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension
Official Title
Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Saturation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Experimental
Arm Title
Desflurane
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane %2-3 for general anesthesia maintenance
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Desflurane %6-8 for general anesthesia maintenance
Primary Outcome Measure Information:
Title
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Description
The effect of sevoflurane and desflurane on NIRS values
Time Frame
Duration of surgery
Secondary Outcome Measure Information:
Title
Total remifentanil consumption as measured in micrograms
Time Frame
Duration of surgery
Title
The effect of anesthetics on hemodynamic variables
Description
The effects of sevoflurane and desflurane on mean arterial pressure
Time Frame
Duration of surgery
Title
The effect of anesthetics on hemodynamic variables
Description
The effects of sevoflurane and desflurane on heart rate
Time Frame
Duration of surgery
Title
The effect of anesthetics on hemodynamic variables
Description
The effects of sevoflurane and desflurane on bispectral index
Time Frame
Duration of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in American Society of Anesthesiology (ASA) classification I and II Patients undergoing elective septoplasty operation Exclusion Criteria: Patients in ASA classification III and higher Emergency surgery Patients in New York Heart Association classification III-IV Patients with known allergy to drugs used in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ülkü C Köksoy, MD
Organizational Affiliation
Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ufuk University Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

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