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

Phase 3

• Conditions: Intubation Complication
• Interventions: Drug: Nerve block with Lidocain; Drug: Fentanyl; Drug: Midazolam

• Registration Number: NCT01768377
• Lead Sponsor: Tehran University of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-14
• Last Update Submitted: 2013-01-14
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation with Nerve block	Midazolam	Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam
Intubation with Nerve block	Nerve block with Lidocain	Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam
Intubation with sedation	Fentanyl	Sedation with midazolam and analgesia with fentanyl
Intubation with sedation	Midazolam	Sedation with midazolam and analgesia with fentanyl

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Imam Khomeini Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of