Hemodynamic Response to Intubation
The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels
1 other identifier
interventional
60
1 country
1
Brief Summary
This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2016
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
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 26, 2016
July 1, 2016
2 months
July 22, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ischemia modified albumine
ischemia modified albumine levels will be measured as a response to intubation
10 minutes after endotracheal intubation
Study Arms (3)
dexmedetomidine
EXPERIMENTAL0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation
Esmolol
EXPERIMENTAL0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation
Placebo
PLACEBO COMPARATOR20 ml normal saline infused in 5 minutes before intubation
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing elective surgery under general anesthesia
You may not qualify if:
- Patient refusal
- Morbid obesity (BMI\>30)
- Advanced systemic disease
- Hypoalbumiemia
- beta-blocker usage
- Anticipated difficult ventilation and/or intubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ufuk Universitylead
Study Sites (1)
Ufuk University Hospital
Ankara, 06520, Turkey (Türkiye)
Related Publications (1)
Yallapragada SV, Vidadala KS, Vemuri NN, Shaik MS. Comparison of the efficacy of dexmedetomidine with that of esmolol in attenuating laryngoscopic and intubation response after rapid sequence induction. Anesth Essays Res. 2014 Sep-Dec;8(3):383-7. doi: 10.4103/0259-1162.143154.
PMID: 25886340RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share