Emergence AgitationNCT07392983
Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation
A study testing Dexmedetomidine and Midazolam in people with Emergence Agitation, run by Muhammad Aamir Latif at 2 sites in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any gender
- Aged 16-60 years
- Undergoing elective FESS under general anesthesia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Bahawal Victoria Hospital/Quad-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
Bahawal Victoria Hospital/Quid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
About this study
Official title: Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
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.
- Conditions
- Emergence Agitation
- Being tested
- Dexmedetomidine, Midazolam
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.
MidazolamDrug
Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group-D | Experimental | Patients were given a dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minutes prior to the procedure. Receives: 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. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Madiha Ashraf, Principal investigator, Bahawal Victoria Hospital/Quid-e-Azam Medical College, BahawalpurAmbreen Khan, FCPS, Study director, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392983
- Sponsor's protocol ID
- Dr-Madiha-BVH
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07392983
- Acronym / sponsor ID
- Dr-Madiha-BVH
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-D | Experimental | Drug: DexmedetomidinePatients were given a dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minutes prior to the procedure. |
| Group-M | Experimental | Drug: MidazolamPatients received a midazolam injection with a loading dose of 0.02 mg/kg in 10 min prior the procedure. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Any gender
- Aged 16-60 years
- Undergoing elective FESS under general anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure. | Drug | Group-D |
| MidazolamPatients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure. | Drug | Group-M |
Primary outcome
Effectiveness in emergence agitation
Time frame: 90 minutes
The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Midazolam in people with Emergence Agitation, run by Muhammad Aamir Latif at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness in emergence agitation (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.