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

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ClinicalTrials.gov Identifier: NCT01768377
Recruitment Status : Unknown
Verified January 2013 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
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

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. Time required for intubation in seconds [ Time Frame: 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 :
  1. physicians' perception of the difficulty of the procedure [ Time Frame: 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

  2. Number of Participants with Adverse Events [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768377


Contacts
Contact: Mohammad Jalili, MD +98(912)5483998 mjalii@tums.ac.ir

Locations
Iran, Islamic Republic of
Imam Khomeini Hospital Recruiting
Tehran, Iran, Islamic Republic of, 1417613151
Contact: Mohammad Jalili, MD    +98(21)66404377    mjalili@tums.ac.ir   
Principal Investigator: Mohammad Jalili, MD         
Principal Investigator: Amir Nejati, MD         
Sub-Investigator: Arsalan Azizpour, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Mohammad Jalili, MD TUMS
Principal Investigator: Amir Nejati, MD TUMS

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01768377     History of Changes
Other Study ID Numbers: 130-1928
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Tehran University of Medical Sciences:
Awake intubation
Nerve block
Sedation
Physician satisfaction

Additional relevant MeSH terms:
Lidocaine
Fentanyl
Midazolam
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents