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

January 14, 2013 updated by: Tehran University of Medical Sciences

Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1417613151
        • Recruiting
        • Imam Khomeini Hospital
        • Contact:
        • Principal Investigator:
          • Mohammad Jalili, MD
        • Principal Investigator:
          • Amir Nejati, MD
        • Sub-Investigator:
          • Arsalan Azizpour, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Midazolam
Midazolam 0.05 mg/kg BW IV infusion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start of the intubation attempt for an average of one minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within an average of 30 minutes after completion of the procedure
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
From the start of the procedure until 30 minutes after the procedure is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130-1928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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