Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

NCT ID: NCT02104297

Last Updated: 2014-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Deksmedetomidine infusion

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

Group Type ACTIVE_COMPARATOR

deksmedetomidine

Intervention Type DRUG

deksmedetomidine infused during operation 0.2 mcg/kg/hour

Remifentanil infusion

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

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Remifentanil infused during operation 0.2 mcg/kg/min

Saline infusion

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

During operation saline infused equal volüme of deksmedetomidine and remifentanil

Interventions

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deksmedetomidine

deksmedetomidine infused during operation 0.2 mcg/kg/hour

Intervention Type DRUG

Remifentanil

Remifentanil infused during operation 0.2 mcg/kg/min

Intervention Type DRUG

Saline

During operation saline infused equal volüme of deksmedetomidine and remifentanil

Intervention Type DRUG

Other Intervention Names

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Precedex Ultiva

Eligibility Criteria

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Inclusion Criteria

* Adult patients

Exclusion Criteria

* patients with any sensitivity each drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reyhan Polat, MD

Role: PRINCIPAL_INVESTIGATOR

Yildirim Beyazit Education and Research Hospita

Locations

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Reyhan Polat

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Reyhan Polat, MD

Role: CONTACT

+905326734310

Facility Contacts

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Reyhan Polat, MD

Role: primary

+905326734310

Other Identifiers

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Agitation

Identifier Type: -

Identifier Source: org_study_id

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