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NCT Number: NCT07502651

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- conducted on 32 subject to assess depth of sedation by using OAA/S and assess effect on bp and heart rate

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Key information

Conditions

Sedation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Post Graduate Institute of Dental Science , Department of Oral Surgery

Rohtak, Haryana, 124001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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.

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.

Primary outcomes

  1. evaluate the depth of sedation by using observer assessment of alertness /sedation scale (OAA/S).

    Time frame: 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.

  2. "COMPARISON OF THE EFFICACY OF INTRANASAL MIDAZOLAM AND DEXMEDETOMIDINE AS A SEDATIVE AGENT IN SURGICAL MANAGEMENT OF ISOLATED MANDIBLE FRACTURE- A PROSPECTIVE RANDOMISED STUDY"

    Time frame: 18month

    observer assessment of alertness

    /sedation scale (OAA/S) o

Interested in participating?

Enrolling by invitation

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

COMPARISON OF THE EFFICACY OF INTRANASAL MIDAZOLAM AND DEXMEDETOMIDINE AS A SEDATIVE AGENT IN SURGICAL MANAGEMENT OF ISOLATED MANDIBLE FRACTURE- A PROSPECTIVE RANDOMISED STUDY"

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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