a Prospective Randomised Study Evaluating the Efficacy of Intranasal Midazolam and Dexmedetomidine as a Sedative Agent in Management of Mandible Fracture

NCT07502651 · tracked via the Priya Life Science India tracker

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Phase

Early Phase 1

Started

2025-05-25

Last updated

2026-03-31

Condition(s) studied

Sedation

Investigational drug(s) / intervention(s)

Midazolam (Intranasal) →Dexmedetomidine (Intranasal) →

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