Subcutaneous NTG for US Radial Artery Cannulation

Morbid Obesity Clinical Trial

— NTG-US-art  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006640
• Other study ID #: Refa-NTG-art
• Status: Completed
• Phase: N/A
• First received: December 27, 2016
• Last updated: December 27, 2016
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients, difficult sampling and problems encountered with noninvasive blood pressure monitoring makes arterial cannulation an essential skill in many situations like surgeries or trans-radial procedures for coronary or carotid interventions.

Radial artery has been preferred over other sites for arterial cannulation due to low incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming to decrease insertion time, increase success rate and decrease related complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• morbid obese indicated for radial artery cannuulation

Exclusion Criteria:

• +ve allen test peripheral arterial disease refusal

Study Design

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• Subcutaneous nitroglycrin
In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
• Subcutaneous saline
In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AlRefaey Kandeel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate		24 hours after surgery	Yes