Does Stellate Ganglion Block Decrease Stress Response of Intubation?

NCT ID: NCT02732093

Last Updated: 2016-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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

Conditions

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Intubation Stellate Ganglion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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stellate block

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

Group Type ACTIVE_COMPARATOR

stellate block

Intervention Type PROCEDURE

lidocaine 2%

Intervention Type DRUG

control

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

Group Type PLACEBO_COMPARATOR

stellate block

Intervention Type PROCEDURE

Na.Cl 0.9% (placebo)

Intervention Type DRUG

Interventions

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stellate block

Intervention Type PROCEDURE

Na.Cl 0.9% (placebo)

Intervention Type DRUG

lidocaine 2%

Intervention Type DRUG

Other Intervention Names

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cervicothoracic ganglion block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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abdelraheem elawamy

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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abdelraheem Elawamy, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut University hospitals

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Abdelraheem Elawamy, MD

Role: CONTACT

00201000032655

Facility Contacts

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abdelraheem Elawamy, MD

Role: primary

00201000032655

Other Identifiers

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irb00008718/654

Identifier Type: -

Identifier Source: org_study_id

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