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

NCT01768377 | Unknown Phase 3 DMC

• 1 other identifier: 130-1928
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation Complication

Keywords

Awake intubation; Nerve block; Sedation; Physician satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of the intubation attempt for an average of one minutes

Secondary Outcomes (2)

• physicians' perception of the difficulty of the procedure

  Within an average of 30 minutes after completion of the procedure

• Number of Participants with Adverse Events

  From the start of the procedure until 30 minutes after the procedure is completed

Study Arms (2)

Intubation with sedation

ACTIVE COMPARATOR

Sedation with midazolam and analgesia with fentanyl

Drug: Fentanyl; Drug: Midazolam

Intubation with Nerve block

EXPERIMENTAL

Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam

Drug: Nerve block with Lidocain; Drug: Midazolam

Interventions

Nerve block with Lidocain DRUG

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

Intubation with Nerve block

Fentanyl DRUG

Fentanyl 2 microgram/Kg BW IV

Intubation with sedation

Midazolam DRUG

Midazolam 0.05 mg/kg BW IV infusion

Intubation with Nerve block; Intubation with sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for intubation with methods other than RSI
• Age\>= 18 years
• Patient or patient's guardian's consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital

Tehran, Tehran Province, 1417613151, Iran

RECRUITING

MeSH Terms

Interventions

Nerve Block; Fentanyl; Midazolam

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mohammad Jalili, MD

  TUMS

  STUDY DIRECTOR

• Amir Nejati, MD

  TUMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Jalili, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2013
• First Posted: January 15, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

IR (1)