Dexmedetomidine for Laryngeal Mask Airway Insertion

Drug Usage Clinical Trial

Official title:

Optimal Dose of Dexmedetomidine for Laryngeal Mask Airway Insertion During Propofol Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852539
• Other study ID #: AJIRB-MED-CT4-13-045
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2013
• Last updated: April 20, 2014
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

Description:

After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr)

Exclusion Criteria:

• G-E reflux

• obesity (BMI>30)

• anticipated difficult airway

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Usage

Intervention

Drug:
• dexmedetomidine
The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 µg/kg (0.1 µg/kg as a step size).
• propofol
Propofol 2.0 mg/kg was administrated

Device:
• laryngeal mask airway (LMA)
The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Uzümcügil F, Canbay O, Celebi N, Karagoz AH, Ozgen S. Comparison of dexmedetomidine-propofol vs. fentanyl-propofol for laryngeal mask insertion. Eur J Anaesthesiol. 2008 Aug;25(8):675-80. doi: 10.1017/S0265021508004213. Epub 2008 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful insertion of LMA	the response of patients to the insertion of LMA (classified as either 'movement' or 'no movement') during infusion of dexmedetomidine and propofol.	from baseline to 2 min after insertion of LMA (participants will be followed for the duration of anesthetic induction, an expected average of 10 min).	Yes