Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation with sedation | Active Comparator | Sedation with midazolam and analgesia with fentanyl |
|
| Intubation with Nerve block | Experimental | Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| physicians' perception of the difficulty 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 | Within an average of 30 minutes after completion of the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Jalili, MD | Contact | +98(912)5483998 | mjalii@tums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad Jalili, MD | TUMS | Study Director |
| Amir Nejati, MD | TUMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Khomeini Hospital | Recruiting | Tehran | Tehran Province | 1417613151 | Iran |
Not provided
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fentanyl | Drug | Fentanyl 2 microgram/Kg BW IV |
|
| Midazolam | Drug | Midazolam 0.05 mg/kg BW IV infusion |
|
| Number of Participants with Adverse Events | 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 | From the start of the procedure until 30 minutes after the procedure is completed |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |