Determine the ED50 of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction
To Determine the Median Effective Dose (ED50) of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction With Propofol 2.0 mg/kg
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMarch 12, 2015
December 1, 2014
5 months
March 6, 2015
March 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
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
Study Arms (1)
Dexmedetomidine
EXPERIMENTALAfter 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).
Interventions
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)
Eligibility Criteria
You may qualify if:
- ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.5～25
You may not qualify if:
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- Chronic renal failure
- Alcohol or drug abuse
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate chief physician
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 12, 2015
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 12, 2015
Record last verified: 2014-12