PropofolPhase 4NCT07907796
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
A Phase 4 study testing Ketamine-Propofol and Sevoflurane in people with Propofol and Ketamine, run by Rawalpindi Institute of Cardiology at 1 site in Pakistan.
Trial summary
Children undergoing cardiac catheterization will be given anesthesia using either a combination of propofol and ketamine or sevoflurane gas. The time taken to fall asleep will be recorded. During the procedure, anesthesia will be maintained to keep the child asleep and comfortable. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Propofol, Ketamine, General Anesthetic Drug Adverse Reaction
- What is being tested?
- Ketamine-Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2026to 25 Jan 2027
- 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
- No healthy volunteers
- Child
Who may be able to join
- Weighing 10-30kg
- ASA I-III of either sex
- Undergoing cardiac catheterization
Who cannot join
- History of Drug Allergy
- Pre-existing Asthma
- Renal or Hepatic dysfunction
- Difficult/prolonged intubation
- Congenital airway abnormalities
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
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province
Asma Shabbir, MBBS, FCPS, +92 333 5161142, Research@ricrwp.edu.pk
About this study
Official title: COMPARISON OF PROPOFOL AND KETAMINE WITH SEVOFLURANE FOR LARYNGEAL MASK ANESTHESIA FOR CARDIAC CATHETERIZATION OF PEDIATRIC PATIENTS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI
Children undergoing cardiac catheterization will be given anesthesia using either a combination of propofol and ketamine or sevoflurane gas. The time taken to fall asleep will be recorded. During the procedure, anesthesia will be maintained to keep the child asleep and comfortable. After the procedure, the time taken to remove the breathing device and the time required for recovery will be recorded. In the recovery area, children will be assessed for emergence delirium (agitation, restlessness, or confusion while waking up from anesthesia) at 0, 5, 10, 15, and 60 minutes. Children who develop significant emergence delirium will receive an appropriate dose of medication to manage the condition, provided there are no medical reasons to avoid its use.
Read the detailed description
Patients meeting the inclusion criteria will be enrolled in the study and randomly allocated using computer-generated random numbers. Anesthesia will be induced using either intravenous ketamine (1.5 mg/kg) combined with propofol (1 mg/kg) or inhalational sevoflurane at 2-3 minimum alveolar concentration (MAC) until an adequate depth of anesthesia is achieved. The time to loss of consciousness will be recorded in seconds.
Anesthesia will be maintained with a propofol infusion at 50-150 µg/kg/min and a ketamine infusion at 25-50 µg/kg/min, titrated to maintain an adequate depth of anesthesia, or with sevoflurane at 2%, targeting a MAC of 1.2, without the addition of other sedative agents.
At the end of the procedure, the time to laryngeal mask airway (LMA) removal and recovery time will be recorded in seconds. Patients will subsequently be transferred to the post-anesthesia care unit (PACU), where emergence delirium will be assessed using the Pediatric Anesthesia Emer
- Conditions
- Propofol, Ketamine, General Anesthetic Drug Adverse Reaction
- Being tested
- Ketamine-Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine-PropofolDrug
Patients will receive intravenous administration of ketamine (1.5 mg/kg) and propofol (1mg/kg) for induction
SevofluraneDrug
Patients will undergo Inhalational induction with Sevoflurane at 2-3 MAC
| Study group | Role | What they receive |
|---|---|---|
| Group-KetoFol | Active comparator | Not described Receives: Drug: Ketamine-Propofol |
| Group Sevoflurane | Active comparator | Not described Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium (PAED) Score
Measured: Post operatively at 0,5,10,15,60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start24 Oct 2026
- Primary completion24 Jan 2027 (estimated)
- Study completion25 Jan 2027 (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 PropofolStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Institute of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasreen Qaisrani, Rawalpindi Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907796
- Sponsor's protocol ID
- RIC/RERC/30/26
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital Ethical Committee doesn't allow
Publications
Basra GS, Joshi A, Jaiswal A, Garg A. Comparison of Propofol and Ketamine with Sevoflurane for Laryngeal Mask Anesthesia for Cardiac Catheterization of Pediatric Patients. J Med Sci Health. 2020 Oct 10;6(2):14-8.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF PROPOFOL AND KETAMINE WITH SEVOFLURANE FOR LARYNGEAL MASK ANESTHESIA FOR CARDIAC CATHETERIZATION OF PEDIATRIC PATIENTS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI
- ClinicalTrials.gov ID
- NCT07907796
- Acronym / sponsor ID
- RIC/RERC/30/26
- Conditions
- Propofol, Ketamine, General Anesthetic Drug Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Rawalpindi Institute of CardiologyUniversity, hospital or other
- Study start
- 24 Oct 2026 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 30 Oct 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.
Children undergoing cardiac catheterization will be given anesthesia using either a combination of propofol and ketamine or sevoflurane gas. The time taken to fall asleep will be recorded. During the procedure, anesthesia will be maintained to keep the child asleep and comfortable. After the procedure, the time taken to remove the breathing device and the time required for recovery will be recorded. In the recovery area, children will be assessed for emergence delirium (agitation, restlessness, or confusion while waking up from anesthesia) at 0, 5, 10, 15, and 60 minutes. Children who develop significant emergence delirium will receive an appropriate dose of medication to manage the condition, provided there are no medical reasons to avoid its use.
Detailed description
Patients meeting the inclusion criteria will be enrolled in the study and randomly allocated using computer-generated random numbers. Anesthesia will be induced using either intravenous ketamine (1.5 mg/kg) combined with propofol (1 mg/kg) or inhalational sevoflurane at 2-3 minimum alveolar concentration (MAC) until an adequate depth of anesthesia is achieved. The time to loss of consciousness will be recorded in seconds.
Anesthesia will be maintained with a propofol infusion at 50-150 µg/kg/min and a ketamine infusion at 25-50 µg/kg/min, titrated to maintain an adequate depth of anesthesia, or with sevoflurane at 2%, targeting a MAC of 1.2, without the addition of other sedative agents.
At the end of the procedure, the time to laryngeal mask airway (LMA) removal and recovery time will be recorded in seconds. Patients will subsequently be transferred to the post-anesthesia care unit (PACU), where emergence delirium will be assessed using the Pediatric Anesthesia Emer
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-KetoFol | Active comparator | Drug: Ketamine-Propofol |
| Group Sevoflurane | Active comparator | Drug: Sevoflurane |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Weighing 10-30kg
- ASA I-III of either sex
- Undergoing cardiac catheterization
Key exclusion criteria (5 listed)
- History of Drug Allergy
- Pre-existing Asthma
- Renal or Hepatic dysfunction
- Difficult/prolonged intubation
- Congenital airway abnormalities
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 |
|---|---|---|
| Ketamine-PropofolPatients will receive intravenous administration of ketamine (1.5 mg/kg) and propofol (1mg/kg) for induction | Drug | Group-KetoFol |
| SevofluranePatients will undergo Inhalational induction with Sevoflurane at 2-3 MAC | Drug | Group Sevoflurane |
Primary outcome
Pediatric Anesthesia Emergence Delirium (PAED) Score
Time frame: Post operatively at 0,5,10,15,60 minutes
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 30 Oct 2026.
- BackgroundBasra GS, Joshi A, Jaiswal A, Garg A. Comparison of Propofol and Ketamine with Sevoflurane for Laryngeal Mask Anesthesia for Cardiac Catheterization of Pediatric Patients. J Med Sci Health. 2020 Oct 10;6(2):14-8.
- Individual participant dataSharing planned: No. Hospital Ethical Committee doesn't 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.
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 Ketamine-Propofol and Sevoflurane in people with Propofol and Ketamine, run by Rawalpindi Institute of Cardiology 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 3 inclusion and 5 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 30 Oct 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 Nasreen Qaisrani, MBBS (+92-3317318740, drnasreenqaisrani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium (PAED) Score (time frame: Post operatively at 0,5,10,15,60 minutes). 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 NCT07907796, 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 30 Oct 2026.