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

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02386462
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Dexmedetomidine; Drug: Propofol	Phase 4

Detailed 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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: To Determine the Median Effective Dose (ED50) of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction With Propofol 2.0 mg/kg
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2015
• Anticipated Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine After an injection of pre-determined bolus dose of dexmedetomidine over 10 min, anaesthesia was induced with propofol 2.0 mg/kg. 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).	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); Drug: Propofol

Outcome Measures

Primary Outcome Measures

1. 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) [5min after the end of the infusion]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ASA Ⅰ ~ Ⅱ 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong	China	510010

Sponsors and Collaborators

• Guangzhou General Hospital of Guangzhou Military Command

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
• ClinicalTrials.gov Identifier: NCT02386462
• Other Study ID Numbers: LMA insertion
• First Posted: Mar 12, 2015
• Last Update Posted: Mar 12, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command: laryngeal mask airway; circulatory reflexes
• Additional relevant MeSH terms: Dexmedetomidine; Propofol

Study Results

No Results Posted as of Mar 12, 2015