The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

Airway Extubation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513772
• Other study ID #: 4-2011-0742
• Status: Completed
• Phase: N/A
• First received: January 16, 2012
• Last updated: August 7, 2012
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

• age = 20,

• ASA class I and II,

• nasal surgery

Exclusion Criteria:

• bradycardia (< 45 bpm),

• heart block,

• liver failure,

• renal failure,

• uncontrolled hypertension,

• body mass index = 30 kg/m2

Study Design

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

Related Conditions & MeSH terms

• Airway Extubation

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine(4?/mL) : 0.4?/kg/hr infusion until extubation
• Normal saline 0.9%
Normal saline(guess as 4?/mL) : 0.4?/kg/hr infusion until extubation

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence agitation		20min	Yes
Secondary	Postoperative quality of recovery		1 day	No