NCT04904965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

May 12, 2021

Last Update Submit

March 5, 2023

Conditions

AnesthesiaSurgeryNeonateDepth of Anesthesia

Keywords

propofolneonatedeph of anesthesiaElectroencephalographysurgery

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Arterial Pressure

    From induction of anesthesia until surgery starts, average 20 minutes.

  • Heart Rate

    From induction of anesthesia until surgery starts, average 20 minutes.

  • Depth of anesthesia

    before the induction of anesthesia until the surgery starts, every 10 minutes. An average of 30 minutes.

  • Propofol plasma concentration

    from induction of anesthesia up to 20 minutes.

  • Motor response to surgical incision

    at first surgical incision (average 1 minute).

Study Arms (4)

Propofol Group 1

EXPERIMENTAL

Patients will receive induction of anesthesia with Propofol at a rate of 2.0 mg/kg/hr.

Drug: Propofol Group 1

Propofol Group 2

EXPERIMENTAL

Patients will receive induction of anesthesia with Propofol at a rate of 4.0 mg/kg/hr.

Drug: Propofol Group 2

Propofol Group 3

EXPERIMENTAL

Patients will receive induction of anesthesia with Propofol at a rate of 6.0 mg/kg/hr.

Drug: Propofol Group 3

Propofol Group 4

EXPERIMENTAL

Patients will receive induction of anesthesia with Propofol at a rate of 8.0 mg/kg/hr.

Drug: Propofol Group 4

Interventions

Propofol Group 1DRUG

Propofol 2.0 mg/kg/hr per 10 min

Also known as: Group 1
Propofol Group 1
Propofol Group 2DRUG

Propofol 4.0 mg/kg/hr per 10 min

Also known as: Group 2
Propofol Group 2
Propofol Group 3DRUG

Propofol 6.0 mg/kg/hr per 10 min

Also known as: Group 3
Propofol Group 3
Propofol Group 4DRUG

Propofol 8.0 mg/kg/hr per 10 min

Also known as: Group 4
Propofol Group 4

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Perinatal asphyxia
  • Evidence of severe neurological injury.
  • Suspected or diagnosed brain malformations
  • Uncontrolled metabolic and hemodynamic instability at the time of surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 450881, Chile

Location

Related Publications (5)

  • 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.

    PMID: 20510792BACKGROUND

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

    PMID: 21383227BACKGROUND

  • 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.

    PMID: 20403936BACKGROUND

  • 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.

    PMID: 31609437BACKGROUND

  • Boncompte G, Cortinez LI, Toso A, Giordano A, Cruzat F, Fuentes R, Pedemonte JC, Contreras V, Biggs D, Chiu E, Ibacache M. Differential effects of propofol anaesthesia across three amplitude-defined electroencephalographic states in sedated critically ill term neonates: An observational study. Eur J Anaesthesiol. 2025 Oct 1;42(10):889-898. doi: 10.1097/EJA.0000000000002208. Epub 2025 May 23.

    PMID: 40420743DERIVED

Study Officials

  • Mauricio C Ibacache, PhD, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 27, 2021

Study Start

May 3, 2021

Primary Completion

December 3, 2022

Study Completion

March 3, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)