Determine the ED50 of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction

Anesthesia Clinical Trial

Official title:

To Determine the Median Effective Dose (ED50) of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction With Propofol 2.0 mg/kg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02386462
• Other study ID #: LMA insertion
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2015
• Last updated: March 11, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2014
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: bo xu
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway (LMA) insertion with minimal effect on respiratory function. The purpose of the study was to determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion during anaesthesia induction with propofol 2.0 mg/kg.

Description:

Dexmedetomidine is a highly selective α2 receptor agonist, which produces sedative, anxiolytic and analgesic effects without causing clinically significant respiratory depression. Dexmedetomidine also reduces the propofol requirement for sedation and anaesthesia induction. Therefore, dexmedetomidine may be a useful co-induction agent to facilitate LMA insertion with minimal effects on respiratory function. A recent study showed that dexmedetomidine administration prior to propofol induction provided similar conditions for successful LMA insertion, as does fentanyl without respiratory depression. The purpose of this study was to determine the median effective dose (ED50) of dexmedetomidine required for successful LMA insertion during induction with propofol of 2 mg/kg .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? women undergoing Laparoscopic surgery.

2. Written informed consent from the patient or the relatives of the participating patient.

3. BMI:18.5~25

Exclusion Criteria:

1. Mental illness can not match

2. epidural anesthesia contraindicated

3. People who have Slow-type arrhythmias

4. Chronic renal failure

5. Alcohol or drug abuse

6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine
The modified Dixon's up-and-down method was used to determine the bolus dose of dexmedetomidine, starting from 1.0µg/kg (step size; 0.1µg/kg)
• Propofol

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment of sedation (determine the effect-site dose of dexmedetomidine blunting cardiovascular responses to the insertion of the laryngeal mask airway at the same level of sedation)	The aim of this study was to determine the effect-site dose of dexmedetomidine blunting cardiovascular responses to the insertion of the laryngeal mask airway at the same level of sedation.	5min after the end of the infusion	No