Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

Agitation Clinical Trial

— EA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02104297
• Other study ID #: Agitation
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 2, 2014
• Last updated: April 3, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Reyhan Polat, MD
• Phone: +905326734310
• Email: reyhanp9[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients

Exclusion Criteria:

• patients with any sensitivity each drug

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• deksmedetomidine
deksmedetomidine infused during operation 0.2 mcg/kg/hour
• Remifentanil
Remifentanil infused during operation 0.2 mcg/kg/min
• Saline
During operation saline infused equal volüme of deksmedetomidine and remifentanil

Locations

Country	Name	City	State
Turkey	Reyhan Polat	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses postoperative agitation score by Riker sedation agitation scale		Postoperative first hour	No
Secondary	Yo asses postoperative side effects emesis, vomitting or pain		Postoperative first hour	No