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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01768377

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	Drug: Nerve block with Lidocain Drug: Fentanyl Drug: Midazolam	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2013

Anticipated Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intubation with sedation Sedation with midazolam and analgesia with fentanyl	Drug: Fentanyl Fentanyl 2 microgram/Kg BW IV Drug: Midazolam Midazolam 0.05 mg/kg BW IV infusion
Experimental: Intubation with Nerve block Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam	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 Drug: Midazolam Midazolam 0.05 mg/kg BW IV infusion

Arm

Intervention/Treatment

Active Comparator: Intubation with sedation

Sedation with midazolam and analgesia with fentanyl

Drug: Fentanyl

Fentanyl 2 microgram/Kg BW IV

Drug: Midazolam

Midazolam 0.05 mg/kg BW IV infusion

Experimental: Intubation with Nerve block

Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam

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

Drug: Midazolam

Midazolam 0.05 mg/kg BW IV infusion

Outcome Measures

Primary Outcome Measures

Time required for intubation in seconds [From start of the intubation attempt for an average of one minutes]
The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.

Secondary Outcome Measures

physicians' perception of the difficulty of the procedure [Within an average of 30 minutes after completion 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
Number of Participants with Adverse Events [From the start of the procedure until 30 minutes after the procedure is completed]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imam Khomeini Hospital	Tehran		Iran, Islamic Republic of	1417613151

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Director: Mohammad Jalili, MD, TUMS
Principal Investigator: Amir Nejati, MD, TUMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01768377

Other Study ID Numbers:

130-1928

First Posted:

Jan 15, 2013

Last Update Posted:

Jan 15, 2013

Last Verified:

Jan 1, 2013

Keywords provided by Tehran University of Medical Sciences

Awake intubation

Nerve block

Sedation

Physician satisfaction

Additional relevant MeSH terms:

Lidocaine

Fentanyl

Midazolam

Study Results

No Results Posted as of Jan 15, 2013