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Clinical trial

Effect of Ketamin+Propofol Mixture on Postoperative Recovery

ID
Name
Ketamin-propofol
Description
ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.
Trial arms
Trial start
2021-02-15
Estimated PCD
2022-12-15
Trial end
2022-12-15
Status
Completed
Phase
Early phase I
Treatment
Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Arms:
Ketofol1/1, Ketofol1/2, Ketofol1/3, propofol
Other names:
ketofol
Size
112
Primary endpoint
Delirium score
30 minutes in PACU
Eligibility criteria
Inclusion Criteria: * ASA I-II patients * Underwent adenoidectomy-tonsillectomy surgery * Age between 3-12 Exclusion Criteria: * ASA III-IV patients * Age; under 3 years old * Age; above 12 years old.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 112, 'type': 'ACTUAL'}}
Updated at
2023-04-20

1 organization

1 drug

1 indication

Organization
Cukurova University
Drug
Ketamine
Indication
Postoperative Recovery