Hemodynamic Response to Intubation

July 25, 2016 updated by: Perihan Ekmekçi, Ufuk University

The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06520
        • Recruiting
        • Ufuk University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

  • Patient refusal
  • Morbid obesity (BMI>30)
  • Advanced systemic disease
  • Hypoalbumiemia
  • beta-blocker usage
  • Anticipated difficult ventilation and/or intubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine
0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation
Drug: Dexmedetomidine
Experimental: Esmolol
0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation
Drug: Esmolol
Placebo Comparator: Placebo
20 ml normal saline infused in 5 minutes before intubation
Drug: Placebo
normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemia modified albumine
Time Frame: 10 minutes after endotracheal intubation
ischemia modified albumine levels will be measured as a response to intubation
10 minutes after endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ufuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RespToIntubation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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