Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation

NCT07392983 | Completed

• 1 other identifier: Dr-Madiha-BVH
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

Since the frequency of emergence agitation (EA) is relatively high in children while undergoing nasal surgery, and there is not much data available in Pakistan regarding EA in adults undergoing functional endoscopic sinus surgery (FESS). Hence there is a need to conduct this study in the local population to see the effect of dexmedetomidine and midazolam on EA. Therefore, the current study was initiated, aiming to compare the effect of dexmedetomidine and midazolam on EA in patients undergoing FESS.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• Effectiveness in emergence agitation

  The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'.

  90 minutes

Study Arms (2)

Group-D

EXPERIMENTAL

Patients were given a dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minutes prior to the procedure.

Drug: Dexmedetomidine

Group-M

EXPERIMENTAL

Patients received a midazolam injection with a loading dose of 0.02 mg/kg in 10 min prior the procedure.

Drug: Midazolam

Interventions

Midazolam DRUG

Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.

Group-M

Dexmedetomidine DRUG

Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.

Group-D

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any gender
• Aged 16-60 years
• Undergoing elective FESS under general anesthesia

You may not qualify if:

• Patients with the presence of infection at the site of the blockage
• Epilepsy, myasthenia gravis, or polio (as per history and clinical record)
• Systemic illness (such as cardiac, hepatic, endocrinal or neurological)
• Substance induced disorder
• Psychiatric disorders
• Taking medications, such as alpha 2 agonists, beta blockers' or tricyclic anti-depressants
• Allergies to the medications used

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (2)

Bahawal Victoria Hospital/Quad-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Bahawal Victoria Hospital/Quid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Madiha Ashraf

  Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

  PRINCIPAL INVESTIGATOR

• Ambreen Khan, FCPS

  Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)