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

NCT ID: NCT01768377

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intubation with sedation

Sedation with midazolam and analgesia with fentanyl

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Fentanyl 2 microgram/Kg BW IV

Midazolam

Intervention Type DRUG

Midazolam 0.05 mg/kg BW IV infusion

Intubation with Nerve block

Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam

Group Type EXPERIMENTAL

Nerve block with Lidocain

Intervention Type DRUG

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

Midazolam

Intervention Type DRUG

Midazolam 0.05 mg/kg BW IV infusion

Interventions

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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

Intervention Type DRUG

Fentanyl

Fentanyl 2 microgram/Kg BW IV

Intervention Type DRUG

Midazolam

Midazolam 0.05 mg/kg BW IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Jalili, MD

Role: STUDY_DIRECTOR

TUMS

Amir Nejati, MD

Role: PRINCIPAL_INVESTIGATOR

TUMS

Locations

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Imam Khomeini Hospital

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Jalili, MD

Role: CONTACT

+98(912)5483998

Facility Contacts

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Mohammad Jalili, MD

Role: primary

+98(21)66404377

Other Identifiers

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130-1928

Identifier Type: -

Identifier Source: org_study_id

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