Sedation
Conditions
Brief summary
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
Interventions
DRUGMidazolam (Intranasal)
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.
DRUGDexmedetomidine (Intranasal)
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.
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 should come under the age range of 18-50 year irrespective of gender are considered in this study. patient having mandible fracture except ramus,coronoid,condyle incuded in study using champy principle of osteosynthesis
Exclusion criteria
* 1.patient with any sign and symptom of systemic comorbidity and are those deemed unfit for the procedure under sedation by anesthesist were excluded. 2. Any known allergy to sedative agents and local anesthestic agents and preoperative inflammation at surgical site are also warrented exclusion from study .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the depth of sedation by using observer assessment of alertness /sedation scale (OAA/S). | intraoperative and postoperatively 1 day | 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. |
| "COMPARISON OF THE EFFICACY OF INTRANASAL MIDAZOLAM AND DEXMEDETOMIDINE AS A SEDATIVE AGENT IN SURGICAL MANAGEMENT OF ISOLATED MANDIBLE FRACTURE- A PROSPECTIVE RANDOMISED STUDY" | 18month | observer assessment of alertness /sedation scale (OAA/S) o |
Countries
India
Outcome results
None listed