Comparison of Volatile Anesthetics on Cerebral Oxygenatio... | NCT02834845

Studies
Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

NCT02834845

Sponsor

Ufuk University

Status

Completed

Last Update Posted

Aug 19, 2020Actual

Enrollment

95Actual

Phase

Phase 4

Conditions

Oxygen Saturation

Interventions

Sevoflurane
Desflurane

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jun 24, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2020

Last Update Posted Date

Aug 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental		Drug: Sevoflurane
Desflurane	Experimental		Drug: Desflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Sevoflurane %2-3 for general anesthesia maintenance	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy	The effect of sevoflurane and desflurane on NIRS values	Duration of surgery

Secondary Outcomes

Measure	Description	Time Frame
Total remifentanil consumption as measured in micrograms		Duration of surgery
The effect of anesthetics on hemodynamic variables	The effects of sevoflurane and desflurane on mean arterial pressure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ülkü C Köksoy, MD	Fellow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufuk University Hospital		Ankara			Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D000077335	Desflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

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Browse Branches

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