Does Stellate Ganglion Block Decrease Stress Response of Intubation?

Intubation Clinical Trial

Official title:

Does Stellate Ganglion Block Decrease Stress Response of Intubation?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732093
• Other study ID #: irb00008718/654
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 5, 2016
• Last updated: April 7, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: Assiut University
• Contact: Abdelraheem Elawamy, MD
• Phone: 00201000032655
• Email: arawamyyy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ganglion Cysts
• Intubation
• Stellate Ganglion

Intervention

Procedure:
• stellate block

Drug:
• Na.Cl 0.9% (placebo)

• lidocaine 2%

Locations

Country	Name	City	State
Egypt	Assiut University hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	measured in beat/min.	5 minutes	Yes
Secondary	mean arterial blood pressure	measured in mm.Hg	5 minutes	Yes