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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768377

Enrollment

Registered

2013-01-15

Start date

2012-11-30

Completion date

2013-02-28

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

Awake intubation, Nerve block, Sedation, Physician satisfaction

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

Interventions

DRUGNerve 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

DRUGFentanyl

Fentanyl 2 microgram/Kg BW IV

DRUGMidazolam

Midazolam 0.05 mg/kg BW IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time required for intubation in seconds	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.

Secondary

Measure	Time frame	Description
physicians' perception of the difficulty of the procedure	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
Number of Participants with Adverse Events	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

Countries

Iran

Contacts

Primary ContactMohammad Jalili, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026