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CompletedNCT07392983Updated Feb 6, 2026

Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation

An interventional study of Dexmedetomidine and Midazolam in Emergence Agitation, sponsored by Muhammad Aamir Latif. Completed at 2 sites in Pakistan. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

There is not much local data present on the topic of EA. As the frequency of EA is relatively high, it can lead to any unwanted event, which can lead to other complications in the patients undergoing nasal surgery. Although in some studies dexmedetomidine has been found to significantly reduce the frequency of EA and severity, provide better sedation, and lower the need for postoperative rescue analgesia in patients undergoing FESS, few others have claimed comparable results for midazolam as well. The findings of this study would not only add to the local data but also be helpful in determining a better option in reducing the frequency of this phenomenon in patients undergoing FESS under general anesthesia.

02

Conditions studied

  • Emergence Agitation

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03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 146 is above the median of 120 across 475 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (actual)

Study arms

  • Experimental
    Group-D

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

    Drug: Dexmedetomidine

  • Experimental
    Group-M

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

    Drug: Midazolam

Interventions

  • DrugDexmedetomidine

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

  • DrugMidazolam

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

06

What researchers measure

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'.

    Time frame: 90 minutes

07

Study locations

2 sites
  • Bahawal Victoria Hospital/Quad-e-Azam Medical College
    Bahawalpur, Punjab Province 63100, Pakistan
  • Bahawal Victoria Hospital/Quid-e-Azam Medical College
    Bahawalpur, Punjab Province 63100, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07392983
Lead sponsor
Muhammad Aamir Latif
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
Feb 6, 2026
Start date
Jul 1, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Feb 6, 2026

Study contacts

Madiha Ashraf
principal investigator · Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
Ambreen Khan, FCPS
study director · Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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