Effect of Deksmedetomidine and Remifentanil in Extubation Agitation
EA
The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
1 other identifier
interventional
90
1 country
1
Brief Summary
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 4, 2014
April 1, 2014
2 months
April 2, 2014
April 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To asses postoperative agitation score by Riker sedation agitation scale
Postoperative first hour
Secondary Outcomes (1)
Yo asses postoperative side effects emesis, vomitting or pain
Postoperative first hour
Study Arms (3)
Deksmedetomidine infusion
ACTIVE COMPARATORTo prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Remifentanil infusion
EXPERIMENTALTo prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale.
Saline infusion
PLACEBO COMPARATORSaline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale.
Interventions
deksmedetomidine infused during operation 0.2 mcg/kg/hour
Remifentanil infused during operation 0.2 mcg/kg/min
During operation saline infused equal volüme of deksmedetomidine and remifentanil
Eligibility Criteria
You may qualify if:
- Adult patients
You may not qualify if:
- patients with any sensitivity each drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reyhan Polat
Ankara, 06610, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reyhan Polat, MD
Yildirim Beyazit Education and Research Hospita
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
April 2, 2014
First Posted
April 4, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 4, 2014
Record last verified: 2014-04