Comparison of Intubation With Nerve Block and With Sedation in Awake Patients
This study is currently recruiting participants.
Verified January 2013 by Tehran University of Medical Sciences
Sponsor:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01768377
First received: January 1, 2013
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Intubation Complication |
Drug: Nerve block with Lidocain Drug: Fentanyl Drug: Midazolam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction |
Resource links provided by NLM:
Further study details as provided by Tehran University of Medical Sciences:
Primary Outcome Measures:
- Time required for intubation in seconds [ Time Frame: From start of the intubation attempt for an average of one minutes ] [ Designated as safety issue: No ]The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.
Secondary Outcome Measures:
- physicians' perception of the difficulty of the procedure [ Time Frame: Within an average of 30 minutes after completion of the procedure ] [ Designated as safety issue: No ]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 [ Time Frame: From the start of the procedure until 30 minutes after the procedure is completed ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 70 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intubation with sedation
Sedation with midazolam and analgesia with fentanyl
|
Drug: Fentanyl
Fentanyl 2 microgram/Kg BW IV
Drug: Midazolam
Midazolam 0.05 mg/kg BW IV infusion
|
|
Experimental: Intubation with Nerve block
Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam
|
Drug: 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
Drug: Midazolam
Midazolam 0.05 mg/kg BW IV infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768377
Contacts
| Contact: Mohammad Jalili, MD | +98(912)5483998 | mjalii@tums.ac.ir |
Locations
| Iran, Islamic Republic of | |
| Imam Khomeini Hospital | Recruiting |
| Tehran, Iran, Islamic Republic of, 1417613151 | |
| Contact: Mohammad Jalili, MD +98(21)66404377 mjalili@tums.ac.ir | |
| Principal Investigator: Mohammad Jalili, MD | |
| Principal Investigator: Amir Nejati, MD | |
| Sub-Investigator: Arsalan Azizpour, MD | |
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
| Study Director: | Mohammad Jalili, MD | TUMS |
| Principal Investigator: | Amir Nejati, MD | TUMS |
More Information
No publications provided
| Responsible Party: | Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01768377 History of Changes |
| Other Study ID Numbers: | 130-1928 |
| Study First Received: | January 1, 2013 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Tehran University of Medical Sciences:
|
Awake intubation Nerve block Sedation Physician satisfaction |
Additional relevant MeSH terms:
|
Midazolam Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013