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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Sedation
• Intervention / Treatment: Drug: Midazolam (Intranasal); Drug: Dexmedetomidine (Intranasal)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of Dental Science , Department of Oral Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intranasal Midazolam Group; Patients with isolated mandibular fractures undergoing open reduction and internal fixation (ORIF) under local anesthesia will receive intranasal midazolam for sedation.	Drug: 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.
Experimental: Intranasal Dexmedetomidine Group; Patients with isolated mandibular fractures undergoing open reduction and internal fixation (ORIF) under local anesthesia will receive intranasal dexmedetomidine for sedation.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 25, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Prinkle saxena

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No