A Phase 4 interventional study of Ketamine-Propofol and Sevoflurane in Propofol, Ketamine and General Anesthetic Drug Adverse Reaction, sponsored by Rawalpindi Institute of Cardiology. Recruiting at 1 site in Pakistan. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Rawalpindi Institute of Cardiology · Phase 4, Interventional, and Prevention
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.
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
Rawalpindi Institute of Cardiology is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ketamine-Propofol
Drug: Sevoflurane
Patients will receive intravenous administration of ketamine (1.5 mg/kg) and propofol (1mg/kg) for induction
Patients will undergo Inhalational induction with Sevoflurane at 2-3 MAC
Pediatric Anesthesia Emergence Delirium (PAED) Score
Time frame: Post operatively at 0,5,10,15,60 minutes
Plan to share: No — Hospital Ethical Committee doesn't allow
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Ketofol · Sevoflurane
Rawalpindi Institute of Cardiology