a Prospective Randomised Study Evaluating the Efficacy of Intranasal Midazolam and Dexmedetomidine as a Sedative Agent in Management of Mandible Fracture
Midazolam (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.
Dexmedetomidine (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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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 .
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Post Graduate Institute of Dental Science , Department of Oral Surgery
Rohtak
Haryana
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.