CClinicalTrials.gg
Status unknownNCT02104297EAUpdated Apr 4, 2014

Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

A Phase 4 interventional study of deksmedetomidine and Remifentanil in Agitation, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-04.

Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Agitation

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Keywords

  • Nasal septum operation
  • agitation
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's planned enrollment of 90 is close to the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 66 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients

Exclusion criteria

Exclusion Criteria:

  • patients with any sensitivity each drug
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • 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

  • 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

  • Placebo comparator
    Saline infusion

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

    Drug: Saline

Interventions

  • Drugdeksmedetomidine

    deksmedetomidine infused during operation 0.2 mcg/kg/hour

    Also known as: Precedex

  • DrugRemifentanil

    Remifentanil infused during operation 0.2 mcg/kg/min

    Also known as: Ultiva

  • DrugSaline

    During operation saline infused equal volüme of deksmedetomidine and remifentanil

06

What researchers measure

Primary outcomes

  1. To asses postoperative agitation score by Riker sedation agitation scale

    Time frame: Postoperative first hour

Secondary outcomes

  1. Yo asses postoperative side effects emesis, vomitting or pain

    Time frame: Postoperative first hour

07

Study locations

1 site
  • Reyhan Polat
    Ankara, 06610, Turkey
    • Reyhan Polat, MD · Contact · reyhanp9@gmail.com · +905326734310
    • Reyhan Polat, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02104297
Lead sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible party
Reyhan Polat (Medical Doctor, Diskapi Yildirim Beyazit Education and Research Hospital) — Principal investigator
First posted
Apr 4, 2014
Start date
Apr 2014
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Apr 4, 2014

Study contacts

Reyhan Polat, MD
Contact
reyhanp9@gmail.com
+905326734310
Reyhan Polat, MD
principal investigator · Yildirim Beyazit Education and Research Hospita

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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