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The goal of this clinical trial is to obtain the optimal patient's comfort and cooperation during awake fiberoptic intubation with prototype device. The main question it aims to answer is:
Which drug provides better sedative effect during awake fiberoptic intubation, dexmedetomidine or ketamine- midazolam combination with prototype supraglottic topical anaesthesia device?
Awake fiberoptic intubation is the gold standard technique for managing patients with anticipated difficult airway. Conscious sedation and topical anesthesia is desirable, not only to make the procedure more tolerable and comfortable for the patient but also to ensure optimal intubating conditions. Ideal Topical Anesthesia and sedation regime for Awake fiberoptic intubation should provide comfort, cooperation, hemodynamic stability along with maintenance of spontaneous respiration. Several sedative agents have been assessed in previous studies) for this purpose (like benzodiazepine ,opioids ,ketamine , propofol and dexmedetomidine So it is important to know which has the best sedative effect dexmedetomidine or ketamine - midazolam combination with undisturbed respiratory function .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine group | Active Comparator | patients will receive an intravenous dose of dexmedetomidine at 1 mcg/kg over 10 min in 100 mL normal saline followed by continous infusion of dexmedetomidine at 0.2mcg/kg/h up to 0.7mcg/kg/hr till reaching Ramsay sedation score 2-3 |
|
| ketamine with midazolam Group | Active Comparator | patients will receive midazolam 0.02 mg /kg IV then 2 minutes later take ketamine 0.25 mg/kg IV and we will repeated this mixture till reaching Ramsay sedation score 2-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | In Dexmedetomidine group: patients received an intravenous dose of dexmedetomidine at 1 mcg/kg over 10 min in 100 mL normal saline followed by continous infusion of dexmedetomidine at 0.2mcg/kg/h up to 0.7mcg/kg/hr till reaching Ramsay sedation score 2-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient tolerance | Patient tolerance assessed by independent observer by a five-point fiberoptic intubation comfort score (1 = no reaction, 2 = slight grimacing, 3 = heavy grimacing, 4 = verbal objection, 5 = defensive movement of head and hands | During the procedure of awake fiberoptic intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation score | Intubation score was assessed by vocal cord movement (1 = open, 2 = moving, 3 = closing, 4 = closed) and coughing (1 = none, 2 = one gag or cough only, 3 = >1 gag or cough, but acceptable conditions, 4 = unacceptable conditions) | During the procedure of awake fiberoptic intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time | Intubation time: from introduction of fibroscope till endotracheal tube in place confirmed. | from introduction of fibroscope till endotracheal tube in place confirmed. |
| Mean arterial blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Zagazig University | Zagazig | Sharqia Province | 44511 | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine plus Midazolam | Drug | In Ketamine Midazolam group: patients received midazolam 0.02 mg /kg IV then 2 minutes later take ketamine 0.25 mg/kg IV and we will repeated this mixture till reaching Ramsay sedation score 2-3 |
|
Mean arterial blood pressure ( MAP Measured in mmHg) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation).
| at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation |
| Heart rate | Heart rate ( HR Measured in beat/ minute) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation). | Heart rate assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation |
| Oxygen saturation | Oxygen saturation ( spO2 Measured in percentage) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation). | At five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |