Dexmedetomidine for Laryngeal Mask Airway Insertion

NCT01852539 | Completed Phase 4 DMC

• 1 other identifier: AJIRB-MED-CT4-13-045
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Usage

Keywords

LMA insertion; dexmedetomidine; propofol

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

dexmedetomidine

EXPERIMENTAL

After intravenous infusion of dexmedetomidine for 2 min, propofol 2.0 mg/kg was administrated. And laryngeal mask airway device was inserted(LMA # 3,4).

Drug: dexmedetomidine; Drug: propofol; Device: laryngeal mask airway (LMA)

Interventions

dexmedetomidine DRUG

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).

Also known as: precedex

dexmedetomidine

propofol DRUG

Propofol 2.0 mg/kg was administrated

Also known as: 2% fresofol

dexmedetomidine

laryngeal mask airway (LMA) DEVICE

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

dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• G-E reflux
• obesity (BMI\>30)
• anticipated difficult airway

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, 443-721, South Korea

Location

Related Publications (1)

• Uzumcugil 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.

  PMID: 18400141 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Propofol; Laryngeal Masks

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jong Yeop Kim, MD

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 13, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

KR (1)