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Effect of Deksmedetomidine and Remifentanil in Extubation Agitation (EA)

Primary Purpose

Agitation

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
deksmedetomidine
Remifentanil
Saline
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation focused on measuring Nasal septum operation, agitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients

Exclusion Criteria:

  • patients with any sensitivity each drug

Sites / Locations

  • Reyhan Polat

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Deksmedetomidine infusion

Remifentanil infusion

Saline infusion

Arm Description

To prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.

To prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale.

Saline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.

Outcomes

Primary Outcome Measures

To asses postoperative agitation score by Riker sedation agitation scale

Secondary Outcome Measures

Yo asses postoperative side effects emesis, vomitting or pain

Full Information

First Posted
April 2, 2014
Last Updated
April 3, 2014
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02104297
Brief Title
Effect of Deksmedetomidine and Remifentanil in Extubation Agitation
Acronym
EA
Official Title
The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.
Detailed Description
Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
Keywords
Nasal septum operation, agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deksmedetomidine infusion
Arm Type
Active Comparator
Arm Description
To prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Arm Title
Remifentanil infusion
Arm Type
Experimental
Arm Description
To prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale.
Arm Title
Saline infusion
Arm Type
Placebo Comparator
Arm Description
Saline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Intervention Type
Drug
Intervention Name(s)
deksmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
deksmedetomidine infused during operation 0.2 mcg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Remifentanil infused during operation 0.2 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
During operation saline infused equal volüme of deksmedetomidine and remifentanil
Primary Outcome Measure Information:
Title
To asses postoperative agitation score by Riker sedation agitation scale
Time Frame
Postoperative first hour
Secondary Outcome Measure Information:
Title
Yo asses postoperative side effects emesis, vomitting or pain
Time Frame
Postoperative first hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients Exclusion Criteria: patients with any sensitivity each drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reyhan Polat, MD
Phone
+905326734310
Email
reyhanp9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reyhan Polat, MD
Organizational Affiliation
Yildirim Beyazit Education and Research Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reyhan Polat
City
Ankara
ZIP/Postal Code
06610
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reyhan Polat, MD
Phone
+905326734310
Email
reyhanp9@gmail.com
First Name & Middle Initial & Last Name & Degree
Reyhan Polat, MD

12. IPD Sharing Statement

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Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

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