The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

NCT02284672 | Completed Phase 4 DMC

• 1 other identifier: AJIRB-MED-CT4-14-296
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.

Conditions

Precedex Effect to Propofol Requirement

Outcome Measures

Primary Outcomes (1)

• Fail or success for Laryngeal Mask Airway (LMA) insertion

  Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement

  During inserting LMA and up to 5 seconds after LMA inserion

Study Arms (2)

control

PLACEBO COMPARATOR

After preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

Drug: Normal saline

dexmedetomidine

EXPERIMENTAL

After preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

dexmedetomidine

Normal saline DRUG

control

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients for surgery not exceed more than 2 hours requiring general anesthesia

You may not qualify if:

• history of gastroesophageal reflux High grade obesity Predicted diffiicult airway

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Jiyoung Yoo

Suweon, Kyunggido, 443-380, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ji Young Yoo, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical assistant professor

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

KR (1)