Clinical trial

Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.

Name
200916011
Description
Frequently, neonates hospitalized in neonatology units require anesthesia for surgery. The drugs used for this purpose are opioids and other anesthetics, such as propofol. Currently, the administration of anesthesia is difficult in neonates due to the neurological immaturity of these patients, the scarcity of adequate pharmacological studies, the prolonged use of one or more sedatives prior to surgery and the limited usefulness of current anesthetic monitoring devices in this population. Electroencephalography (EEG), which has allowed estimation of anesthetic depth in other populations, has been less explored in neonates. To date, there are no EEG markers, correlated with a given dose of anesthesia, that allow an adequate administration in this kind of patients. In this context, a better understanding of the anesthetic effect in the neonatal brain would allow defining characteristic EEG patterns, improving the estimation of anesthetic depth and anesthetic dosage in neonates.
Trial arms
Trial start
2021-05-03
Estimated PCD
2022-12-03
Trial end
2023-03-03
Status
Completed
Treatment
Propofol Group 1
Propofol 2.0 mg/kg/hr per 10 min
Arms:
Propofol Group 1
Other names:
Group 1
Propofol Group 2
Propofol 4.0 mg/kg/hr per 10 min
Arms:
Propofol Group 2
Other names:
Group 2
Propofol Group 3
Propofol 6.0 mg/kg/hr per 10 min
Arms:
Propofol Group 3
Other names:
Group 3
Propofol Group 4
Propofol 8.0 mg/kg/hr per 10 min
Arms:
Propofol Group 4
Other names:
Group 4
Size
20
Primary endpoint
Electroencephalography monitoring slow bands
10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Electroencephalography monitoring alpha bands
10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Electroencephalography monitoring Theta bands
10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Eligibility criteria
Inclusion Criteria: * Term newborns (\>37 weeks) admitted to the NICU * Diagnosis of surgical pathology, non-neurological, to be resolved in the NICU, in the next hours or days. * Need for continuous sedation-analgesia prior to surgery. Exclusion criteria: * Perinatal asphyxia * Evidence of severe neurological injury. * Suspected or diagnosed brain malformations * Uncontrolled metabolic and hemodynamic instability at the time of surgery.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Patients will be randomized into 4 groups, of 5 patients each, to receive total intravenous anesthesia, with different propofol induction infusion rates: Group 1 (Propofol 2.0 mg/kg/hr); Group 2 (Propofol 4.0 mg/kg/hr); Group 3 (Propofol 6.0 mg/kg/hr); Group 4 (Propofol 8.0 mg/kg/hr).', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-03-07

1 organization

1 product

4 indications

Product
Propofol
Indication
Anesthesia
Indication
Surgery
Indication
Neonate