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

Tehran University of Medical Sciences70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Intubation Complication

Interventions

Nerve block with LidocainDRUG

Lidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg

FentanylDRUG

Fentanyl 2 microgram/Kg BW IV

MidazolamDRUG

Midazolam 0.05 mg/kg BW IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imam Khomeini Hospital

Tehran, Tehran Province, Iran

RECRUITING

Outcomes

Primary Outcomes

Time required for intubation in seconds

The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.

Time frame: From start of the intubation attempt for an average of one minutes

Secondary Outcomes

physicians' perception of the difficulty 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

Time frame: Within an average of 30 minutes after completion of the procedure

Number of Participants with Adverse Events

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

Time frame: From the start of the procedure until 30 minutes after the procedure is completed

Central Contacts

Mohammad Jalili, MD

CONTACT

+98(912)5483998 mjalii@tums.ac.ir

Data from ClinicalTrials.gov

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