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

NCT ID: NCT02386462

Last Updated: 2015-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

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.

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 .

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Intervention Type: DRUG

Interventions

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)

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

bo xu

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

bo xu

Role: CONTACT

xubo333@hotmail.com

88653387 ext. 020

Facility Contacts

Xu Dong Zhou

Role: primary

13268260337@qq.com

13268260337 ext. 86

Other Identifiers

LMA insertion

Identifier Type: -

Identifier Source: org_study_id