Emergence Delirium, AnesthesiaPhase 4NCT07799311
Comparing the Efficacy of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children
A Phase 4 study testing propofol 1mg/kg and Dexmedetomidine in people with Emergence Delirium, Anesthesia, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This is a clinical study for comparing the efficacy of two drugs i.e propofol and dexmedetomidine in prevention of a group of post operative abnormal behaviours that can occur after sevoflurane anesthesia in children and we will measure this by a special scale which is used to evaluate these behavioural changes. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium, Anesthesia
- What is being tested?
- propofol 1mg/kg and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Aug 2026to 28 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1- age 2-12 years 2-elective inguinal hernia repair under general anesthesia
- -
Who cannot join
- congenital anomalies
- allergic to study medications
- chronic pain syndromes
- malnourishment -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
Naheed Fatima, MBBS,FCPS, 03005236655, naheedfk73@gmail.com
About this study
Official title: Comparison of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia Following Inguinal Hernia Repair: A Randomized Control Trial
This is a clinical study for comparing the efficacy of two drugs i.e propofol and dexmedetomidine in prevention of a group of post operative abnormal behaviours that can occur after sevoflurane anesthesia in children and we will measure this by a special scale which is used to evaluate these behavioural changes.
Read the detailed description
A randomized clinical trial in which we will compare a single dose propofol with a single dose of dexmedetomodine given at the end of surgery after sevoflurane _based anesthesia to prevent post operative emergence agitation which is a group of behaviours consisting of confusion , disorientation,hyperactivity and even physical harm to themselves and others. this behavioural response is assessed by a score which is called peadriatric anesthesia emergence delerium scale (PEAD) which consist of 5-itms and 5-point scale ,ranging from not at all to extremely.the total score range from 0 to 20,with higher scores indicating more svere emergence agitation . In this study , the PEAD score will be recorded at 0,5,10,15,and 30 minutes after the child reach the recovery room ,and score greater than 10 at any of these readings will be taken as emergence agitation or delerium.
- Conditions
- Emergence Delirium, Anesthesia
- Being tested
- propofol 1mg/kg, Dexmedetomidine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol 1mg/kgDrug
1mg/kg propofol given 10 minutes before the end of surgery
DexmedetomidineDrug
0.3mcg/kg of dexmedetomidine to group D patients will be given after dilution with 10ml of 0.9%saline over 1 min given 10 minutes before extubation
| Study group | Role | What they receive |
|---|---|---|
| Group propofol | Active comparator | Not described Receives: Drug: propofol 1mg/kg |
| group dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence Delirium PAED score
Measured: PAED score will be calculated upon arrival in Post Anesthesia care unit then at 5,10,15,30 minutes interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start28 Aug 2026
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence Delirium, AnesthesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences
- Investigators
- Naheed Fatima, Study chair, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799311
- Sponsor's protocol ID
- F/522024(ERRC)PIMS
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical committe doesnt allow
Publications
Ghada F. Amer & Maha Younis Abdallah (2022) Dexmedetomidine versus propofol for prevention of emergence delirium in pediatric cataract surgery: Double blinded randomized study, Egyptian Journal of Anaesthesia, 38:1, 300-304, DOI: 10.1080/11101849.2022.2077049
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia Following Inguinal Hernia Repair: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07799311
- Acronym / sponsor ID
- F/522024(ERRC)PIMS
- Conditions
- Emergence Delirium, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 2 Sep 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.
This is a clinical study for comparing the efficacy of two drugs i.e propofol and dexmedetomidine in prevention of a group of post operative abnormal behaviours that can occur after sevoflurane anesthesia in children and we will measure this by a special scale which is used to evaluate these behavioural changes.
Detailed description
A randomized clinical trial in which we will compare a single dose propofol with a single dose of dexmedetomodine given at the end of surgery after sevoflurane _based anesthesia to prevent post operative emergence agitation which is a group of behaviours consisting of confusion , disorientation,hyperactivity and even physical harm to themselves and others. this behavioural response is assessed by a score which is called peadriatric anesthesia emergence delerium scale (PEAD) which consist of 5-itms and 5-point scale ,ranging from not at all to extremely.the total score range from 0 to 20,with higher scores indicating more svere emergence agitation . In this study , the PEAD score will be recorded at 0,5,10,15,and 30 minutes after the child reach the recovery room ,and score greater than 10 at any of these readings will be taken as emergence agitation or delerium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group propofol | Active comparator | Drug: propofol 1mg/kg |
| group dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1- age 2-12 years 2-elective inguinal hernia repair under general anesthesia
- -
Key exclusion criteria (4 listed)
- congenital anomalies
- allergic to study medications
- chronic pain syndromes
- malnourishment -
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 |
|---|---|---|
| propofol 1mg/kg1mg/kg propofol given 10 minutes before the end of surgery | Drug | Group propofol |
| Dexmedetomidine0.3mcg/kg of dexmedetomidine to group D patients will be given after dilution with 10ml of 0.9%saline over 1 min given 10 minutes before extubation | Drug | group dexmedetomidine |
Primary outcome
Emergence Delirium PAED score
Time frame: PAED score will be calculated upon arrival in Post Anesthesia care unit then at 5,10,15,30 minutes interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- BackgroundGhada F. Amer & Maha Younis Abdallah (2022) Dexmedetomidine versus propofol for prevention of emergence delirium in pediatric cataract surgery: Double blinded randomized study, Egyptian Journal of Anaesthesia, 38:1, 300-304, DOI: 10.1080/11101849.2022.2077049
- Individual participant dataSharing planned: No. Ethical committe doesnt allow
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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.
Naheed Fatima study chair
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol 1mg/kg and Dexmedetomidine in people with Emergence Delirium, Anesthesia, run by Pakistan Institute of Medical Sciences at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haroon Principal Investigator, MBBS, FCPS (+92-333-5236956, haroonanwar22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence Delirium PAED score (time frame: PAED score will be calculated upon arrival in Post Anesthesia care unit then at 5,10,15,30 minutes interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07799311, which also lists 1 linked publication.
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 2 Sep 2026.