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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768377

Locations
Iran, Islamic Republic of
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
  More Information

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:
Lidocaine
Midazolam
Fentanyl
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
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Analgesics, Opioid
Narcotics
Analgesics

ClinicalTrials.gov processed this record on December 09, 2016