Effect of Deksmedetomidine and Remifentanil in Extubation Agitation (EA)

April 3, 2014 updated by: Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation

To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

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
      • Ankara, Turkey, 06610
        • Reyhan Polat

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients

Exclusion Criteria:

  • patients with any sensitivity each drug

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deksmedetomidine infusion
To prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Drug: deksmedetomidine
deksmedetomidine infused during operation 0.2 mcg/kg/hour
Other Names:
  • Precedex
Experimental: Remifentanil infusion
To prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale.
Drug: Remifentanil
Remifentanil infused during operation 0.2 mcg/kg/min
Other Names:
  • Ultiva
Placebo Comparator: Saline infusion
Saline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Drug: Saline
During operation saline infused equal volüme of deksmedetomidine and remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To asses postoperative agitation score by Riker sedation agitation scale
Time Frame: Postoperative first hour
Postoperative first hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Yo asses postoperative side effects emesis, vomitting or pain
Time Frame: Postoperative first hour
Postoperative first hour

Collaborators and Investigators

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

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Principal Investigator: Reyhan Polat, MD, Yildirim Beyazit Education and Research Hospita

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

April 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Agitation

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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