Clinical trial
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
Name
DTH: 22004
Description
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.
Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.
Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.
Trial arms
Trial start
2021-12-01
Estimated PCD
2024-12-15
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Propofol 10 MG/ML Injection
Propofol infusion
Arms:
Group P (n=22)
Sevoflurane Inhalation Liquid
Sevoflurane inhalation
Arms:
Group S (n=22)
Size
44
Primary endpoint
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
24 hours after the end of operation
Eligibility criteria
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 years
* Body Mass Index (BMI) 25-35 kg/m2
Exclusion Criteria:
* ASA physical status \> II
* Age \< 21 years
* Patients with Montreal Objective Cognitive Assessment (MoCA-B) score \< 24 points
* Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
* Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
* Patients on long-term use of sedatives or steroids, alcohol or drug abuse
* Allergy to any of the study drugs
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2024-02-20
1 organization
2 products
1 indication
Organization
Damanhour Teaching HospitalProduct
PropofolIndication
General Anesthetic Drug Adverse ReactionProduct
Sevoflurane Inhalation