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Effect of Deksmedetomidine and Remifentanil in Extubation Agitation (EA)

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ClinicalTrials.gov Identifier: NCT02104297
Recruitment Status : Unknown
Verified April 2014 by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

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

Condition or disease Intervention/treatment Phase
Agitation Drug: deksmedetomidine Drug: Remifentanil Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
Study Start Date : April 2014
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. To asses postoperative agitation score by Riker sedation agitation scale [ Time Frame: Postoperative first hour ]

Secondary Outcome Measures :
  1. Yo asses postoperative side effects emesis, vomitting or pain [ Time Frame: Postoperative first hour ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients

Exclusion Criteria:

  • patients with any sensitivity each drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104297


Contacts
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Contact: Reyhan Polat, MD +905326734310 reyhanp9@gmail.com

Locations
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Turkey
Reyhan Polat Not yet recruiting
Ankara, Turkey, 06610
Contact: Reyhan Polat, MD    +905326734310    reyhanp9@gmail.com   
Principal Investigator: Reyhan Polat, MD         
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Principal Investigator: Reyhan Polat, MD Yildirim Beyazit Education and Research Hospita

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Responsible Party: Reyhan Polat, Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02104297     History of Changes
Other Study ID Numbers: Agitation
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital:
Nasal septum operation
agitation
Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents