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

NCT07502651 | Enrolling By Invitation Early Phase 1

• 1 other identifier: Prinkle saxena
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Sedation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: Midazolam (Intranasal)

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.

Drug: Dexmedetomidine (Intranasal)

Interventions

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.

Intranasal Midazolam Group

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.

Intranasal Dexmedetomidine Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science , Department of Oral Surgery

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal pgids rohtak

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 31, 2026
• Study Start: May 25, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 25, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)