NCT01513772

Brief Summary

The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

January 16, 2012

Last Update Submit

August 7, 2012

Conditions

Airway Extubation

Outcome Measures

Primary Outcomes (1)

  • Emergence agitation

    20min

Secondary Outcomes (1)

  • Postoperative quality of recovery

    1 day

Study Arms (2)

Control

PLACEBO COMPARATOR
Drug: Normal saline 0.9%

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Dexmedetomidine
Normal saline 0.9%DRUG

Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Control

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥ 20,
  • ASA class I and II,
  • nasal surgery

You may not qualify if:

  • bradycardia (\< 45 bpm),
  • heart block,
  • liver failure,
  • renal failure,
  • uncontrolled hypertension,
  • body mass index ≥ 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

KR(1)