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COMPARISON OF THE EFFICACY OF INTRANASAL MIDAZOLAM AND DEXMEDETOMIDINE AS A SEDATIVE AGENT IN SURGICAL MANAGEMENT OF ISOLATED MANDIBLE FRACTURE- conducted on 32 subject to assess depth of sedation by using OAA/S and assess effect on bp and heart rate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Midazolam Group | Active Comparator | Patients with isolated mandibular fractures undergoing open reduction and internal fixation (ORIF) under local anesthesia will receive intranasal midazolam for sedation. |
|
| Intranasal Dexmedetomidine Group | Experimental | Patients with isolated mandibular fractures undergoing open reduction and internal fixation (ORIF) under local anesthesia will receive intranasal dexmedetomidine for sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam (Intranasal) | Drug | Midazolam administered intranasally at a dose appropriate for conscious sedation. Sedation depth will be assessed using the Observer Assessment of Alertness/Sedation (OAA/S) scale. Blood pressure and heart rate will be monitored intraoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the depth of sedation by using observer assessment of alertness /sedation scale (OAA/S). | evaluate the depth of sedation by using observer assessment of alertness /sedation scale (OAA/S) obtained with midazolam and dexmedetomidine drugs used during surgical management of isolated mandible fracture. | intraoperative and postoperatively 1 day |
| "COMPARISON OF THE EFFICACY OF INTRANASAL MIDAZOLAM AND DEXMEDETOMIDINE AS A SEDATIVE AGENT IN SURGICAL MANAGEMENT OF ISOLATED MANDIBLE FRACTURE- A PROSPECTIVE RANDOMISED STUDY" | observer assessment of alertness /sedation scale (OAA/S) o | 18month |
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Inclusion Criteria:.Patient who required surgical intervention for treatment of mandibular fracture under the category of ASA I and ASA II as deemed fit by an anesthesist and are willing to participate included in this study.
patient having mandible fracture except ramus,coronoid,condyle incuded in study using champy principle of osteosynthesis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Dental Science , Department of Oral Surgery | Rohtak | Haryana | 124001 | India |
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| Dexmedetomidine (Intranasal) | Drug | Dexmedetomidine administered intranasally at a dose appropriate for conscious sedation. Sedation depth will be assessed using the Observer Assessment of Alertness/Sedation (OAA/S) scale. Blood pressure and heart rate will be monitored intraoperatively. |
|
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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