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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04904965
Other study ID # 200916011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date March 3, 2023

Study information

Verified date March 2023
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Propofol Group 1
Propofol 2.0 mg/kg/hr per 10 min
Propofol Group 2
Propofol 4.0 mg/kg/hr per 10 min
Propofol Group 3
Propofol 6.0 mg/kg/hr per 10 min
Propofol Group 4
Propofol 8.0 mg/kg/hr per 10 min

Locations

Country Name City State
Chile Pontificia Universidad Catolica de Chile Santiago Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (4)

Anand KJ, Willson DF, Berger J, Harrison R, Meert KL, Zimmerman J, Carcillo J, Newth CJ, Prodhan P, Dean JM, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Tolerance and withdrawal from prolonged opioid use in critically ill children. Pediatrics. 2010 May;125(5):e1208-25. doi: 10.1542/peds.2009-0489. Epub 2010 Apr 19. — View Citation

Andre M, Lamblin MD, d'Allest AM, Curzi-Dascalova L, Moussalli-Salefranque F, S Nguyen The T, Vecchierini-Blineau MF, Wallois F, Walls-Esquivel E, Plouin P. Electroencephalography in premature and full-term infants. Developmental features and glossary. Neurophysiol Clin. 2010 May;40(2):59-124. doi: 10.1016/j.neucli.2010.02.002. Epub 2010 Mar 16. — View Citation

Giordano V, Edobor J, Deindl P, Wildner B, Goeral K, Steinbauer P, Werther T, Berger A, Olischar M. Pain and Sedation Scales for Neonatal and Pediatric Patients in a Preverbal Stage of Development: A Systematic Review. JAMA Pediatr. 2019 Dec 1;173(12):1186-1197. doi: 10.1001/jamapediatrics.2019.3351. — View Citation

Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Electroencephalography monitoring slow bands Power of frequency slow bands, entropy and complexity measures. 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Primary Electroencephalography monitoring alpha bands Power of frequency alpha bands, entropy and complexity measures. 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Primary Electroencephalography monitoring Theta bands Power of frequency Theta bands, entropy and complexity measures. 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Secondary Arterial Pressure By non invasive Arterial Pressure: Systolic Arterial Pressure in mmHg, diastolic Arterial Pressure in mmHg and Medium Arterial Pressure in mmHg, every 5 minutes. From induction of anesthesia until surgery starts, average 20 minutes.
Secondary Heart Rate By EKG D-II, every 5 minutes. From induction of anesthesia until surgery starts, average 20 minutes.
Secondary Depth of anesthesia Evaluated with N-PASS clinical scale. The N-PASS uses five criteria: crying/irritability, behavioral state, facial expression, extremity tone and vital signs. The scale has a range from 0 (normal) to -10 (sedated). before the induction of anesthesia until the surgery starts, every 10 minutes. An average of 30 minutes.
Secondary Propofol plasma concentration Venous or arterial samples will be taken for propofol plasma concentration levels (ng/ml) at two times (10 minutes and 20 minutes from induction of anesthesia). from induction of anesthesia up to 20 minutes.
Secondary Motor response to surgical incision Presence of any body movement at the moment of the first surgical incision. at first surgical incision (average 1 minute).
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