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

T

Tehran University of Medical Sciences

Status and phase

Unknown
Phase 3

Conditions

Intubation Complication

Treatments

Drug: Nerve block with Lidocain
Drug: Fentanyl
Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01768377
130-1928

Details and patient eligibility

About

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

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Intubation with sedation
Active Comparator group
Description:
Sedation with midazolam and analgesia with fentanyl
Treatment:
Drug: Midazolam
Drug: Fentanyl
Intubation with Nerve block
Experimental group
Description:
Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam
Treatment:
Drug: Midazolam
Drug: Nerve block with Lidocain

Trial contacts and locations

1

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Central trial contact

Mohammad Jalili, MD

Data sourced from clinicaltrials.gov

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