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Does Stellate Ganglion Block Decrease Stress Response of Intubation?

Primary Purpose

Intubation, Stellate Ganglion

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
stellate block
Na.Cl 0.9% (placebo)
lidocaine 2%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intubation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective surgery
  • General anesthesia with endotracheal intubation
  • ASA I/II

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity to local anesthetics
  • Coagulopathy
  • Infection at site of injection
  • Patient refusal

Sites / Locations

  • Assiut University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

stellate block

control

Arm Description

patients in this arm will receive ultrasonographic guided left stellate block with 6 ml of lidocaine 2% after routine induction of general anesthesia and before endotracheal intubation

patients in this arm will receive ultrasonographic guided left stellate block with 6 ml normal saline (Na.Cl 0.9%) (control group) after routine induction of general anesthesia and before endotracheal intubation

Outcomes

Primary Outcome Measures

heart rate
measured in beat/min.

Secondary Outcome Measures

mean arterial blood pressure
measured in mm.Hg

Full Information

First Posted
April 5, 2016
Last Updated
April 7, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02732093
Brief Title
Does Stellate Ganglion Block Decrease Stress Response of Intubation?
Official Title
Does Stellate Ganglion Block Decrease Stress Response of Intubation?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study investigators will evaluate the effect of stellate ganglion block on stress response of intubation in comparison to traditional antistress measures in adult patients
Detailed Description
Both groups will have the same general anesthesia procedure, patients in stellate block group will receive lidocaine in the stellate block will in control group patients will receive Na.Cl as placebo. primary outcome will be stress response to subsequent endotracheal intubation measure by changes in heart rate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Stellate Ganglion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stellate block
Arm Type
Active Comparator
Arm Description
patients in this arm will receive ultrasonographic guided left stellate block with 6 ml of lidocaine 2% after routine induction of general anesthesia and before endotracheal intubation
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patients in this arm will receive ultrasonographic guided left stellate block with 6 ml normal saline (Na.Cl 0.9%) (control group) after routine induction of general anesthesia and before endotracheal intubation
Intervention Type
Procedure
Intervention Name(s)
stellate block
Other Intervention Name(s)
cervicothoracic ganglion block
Intervention Type
Drug
Intervention Name(s)
Na.Cl 0.9% (placebo)
Intervention Type
Drug
Intervention Name(s)
lidocaine 2%
Primary Outcome Measure Information:
Title
heart rate
Description
measured in beat/min.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
mean arterial blood pressure
Description
measured in mm.Hg
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgery General anesthesia with endotracheal intubation ASA I/II Exclusion Criteria: Pregnancy Hypersensitivity to local anesthetics Coagulopathy Infection at site of injection Patient refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelraheem Elawamy, MD
Phone
00201000032655
Email
arawamyyy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdelraheem Elawamy, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abdelraheem Elawamy, MD
Phone
00201000032655
Email
arawamyyy@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Does Stellate Ganglion Block Decrease Stress Response of Intubation?

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