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

This study is currently recruiting participants.
Verified January 2013 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01768377
First received: January 1, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Intubation Complication
Drug: Nerve block with Lidocain
Drug: Fentanyl
Drug: Midazolam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Time required for intubation in seconds [ Time Frame: From start of the intubation attempt for an average of one minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within an average of 30 minutes after completion of the procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the start of the procedure until 30 minutes after the procedure is completed ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01768377     History of Changes
Other Study ID Numbers: 130-1928
Study First Received: January 1, 2013
Last Updated: January 14, 2013
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Midazolam
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014