Comparison of Intubation With Nerve Block and With Sedation in Awake Patients

Intubation Complication Clinical Trial

Official title:

Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01768377
• Other study ID #: 130-1928
• Status: Recruiting
• Phase: Phase 3
• First received: January 1, 2013
• Last updated: January 14, 2013
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2013
• Source: Tehran University of Medical Sciences
• Contact: Mohammad Jalili, MD
• Phone: +98(912)5483998
• Email: mjalii[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare intubation with nerve block with intubation with sedation in awake patients in terms of efficacy, ease, and the rate of complications and physician satisfaction

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate for intubation with methods other than RSI

• Age>= 18 years

• Patient or patient's guardian's consent

Exclusion Criteria:

• Need for RSI or crash intubation

• Allergy to Lidocain in block group

• Allergy to opioid drugs in sedation group

• Allergy to midazolam in either group

Study Design

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Drug:
• Nerve block with Lidocain
Lidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg
• Fentanyl
Fentanyl 2 microgram/Kg BW IV
• Midazolam
Midazolam 0.05 mg/kg BW IV infusion

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for intubation in seconds	The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.	From start of the intubation attempt for an average of one minutes	No
Secondary	physicians' perception of the difficulty of the procedure	Physicians' perception about the difficulty of the procedure is assessed using a 5-point Likert type scale (ranging from very easy to very difficult)verbally administered to the healthcare provider immediately (within 30 minutes) after completion of the intubation	Within an average of 30 minutes after completion of the procedure	No
Secondary	Number of Participants with Adverse Events	Number of patients developing any of the following complications (cough, esophageal intubation) from the start of the procedure until 30 minutes after completion of the procedure. This will represent the rate of complications	From the start of the procedure until 30 minutes after the procedure is completed	Yes