AnesthesiaNCT04904965
Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.
A study testing Propofol Group 1, Propofol Group 2 and Propofol Group 3 in people with Anesthesia and Surgery, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Anesthesia, Surgery, Neonate
- What is being tested?
- Propofol Group 1, Propofol Group 2 and Propofol Group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 3 May 2021to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Perinatal asphyxia
- Evidence of severe neurological injury.
- Suspected or diagnosed brain malformations
- Uncontrolled metabolic and hemodynamic instability at the time of surgery.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 450881
About this study
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.
Read the detailed description
As a consequence of the cerebral immaturity of newborns (1,2), together with the fact that in the NICU it is common to find patients requiring surgery who are sedated with multiple drugs, it is necessary to define characteristic EEG patterns that allow estimation of the anesthetic depth and adequate dosage of anesthetics, avoiding the the risk of under- or overdosing of anesthetics (3).
The investigators will conduct an exploratory study. The aim of the study is to determine, by frontal electroencephalography, markers of brain electrical activity associated with the administration of propofol in term newborns requiring surgery in the NICU. A sample of 20 term neonatal patients admitted to the NICU UC with a diagnosis of surgical pathology will be included.
General objective:
To describe the characteristics of the frontal electroencephalographic pattern associated with increasing doses of propofol, in term neonates, requiring surgery in the NICU and its correlation with a clinical response, to the surgical stimulus.
Specific objectives:
- Identify the association between electroencephalographic parameters and different levels of sedation prior to surgery.
- To identify the association between electroencephalographic parameters and increasing doses (plasma concentration) of propofol administered in a previously sedated patient.
- To relate the clinical response observed to the surgical stimulus and increasing doses (plasma concentration) of propofol in a previously sedated patient (dose (concentration) - response curve).
- To describe the temporal profile of propofol anesthesia, based on the changes in electroencephalographic parameters observed over time, during the period of administration and suspension of the anesthetic.
On the scheduled day of surgery in the NICU and prior to anesthetic induction, in sedated and standardly monitored patients (ECG, SpO2, PAI, temperature, diuresis). A four-channel SedLine® monitor (Masimo Corporation, Irvine, CA, USA) will be used to monitor frontal brain electrical activity 10 minutes before the induction of anesthesia. At the end of this period, the level of sedation will be evaluated with the N-PASS clinical scale (4) and the types, doses and duration of sedative drugs administered up to that time will be recorded. Then, patients will be randomized into 4 groups, of 5 patients each, to receive manual total intravenous anesthesia, with different propofol 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/hrs. At 10 and 20 minutes after the start of the propofol infusion, arterial blood samples will be taken to determine the plasma concentration of propofol reached during the anesthetic induction. In case of hemodynamic alteration (heart rate and/or blood pressure drop by 20%) during the propofol infusion, a 25% decrease of the original dose will be performed. At the end of this period, surgery will be initiated. The hemodynamic and motor response to the surgical stimulus will be observed and recorded. If there is hemodynamic response (increase in heart rate and/or blood pressure by 20%) and/or motor response, after the surgical stimulus, fentanyl rescue 5 mcg/kg/iv will be administered. Subsequent anesthesia will be in the hands of the treating anesthesiologist in the doses and forms he/she deems convenient. Electroencephalographic tracing will be maintained continuously throughout the procedure (from 10 minutes before and up to 10 minutes after surgery). Changes and adjustments to the anesthesia and analgesia given, hemodynamic changes occurring during the procedure and anesthetic and surgical times will be recorded.
- Conditions
- Anesthesia, Surgery, Neonate, Depth of Anesthesia
- Being tested
- Propofol Group 1, Propofol Group 2, Propofol Group 3, Propofol Group 4
- Keywords
- propofol, neonate, deph of anesthesia, Electroencephalography, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol Group 1Drug
Also called Group 1
Propofol 2.0 mg/kg/hr per 10 min
Propofol Group 2Drug
Also called Group 2
Propofol 4.0 mg/kg/hr per 10 min
Propofol Group 3Drug
Also called Group 3
Propofol 6.0 mg/kg/hr per 10 min
Propofol Group 4Drug
Also called Group 4
Propofol 8.0 mg/kg/hr per 10 min
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group 1 | Experimental | Patients will receive induction of anesthesia with Propofol at a rate of 2.0 mg/kg/hr. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Propofol Group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography monitoring slow bands
Power of frequency slow bands, entropy and complexity measures.
Measured: 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.
Measured: 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.
Measured: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Secondary outcomes (5)
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.
Measured: From induction of anesthesia until surgery starts, average 20 minutes.
Heart Rate
By EKG D-II, every 5 minutes.
Measured: From induction of anesthesia until surgery starts, average 20 minutes.
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).
Measured: before the induction of anesthesia until the surgery starts, every 10 minutes. An average of 30 minutes.
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).
Measured: from induction of anesthesia up to 20 minutes.
Motor response to surgical incision
Presence of any body movement at the moment of the first surgical incision.
Measured: at first surgical incision (average 1 minute).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start3 May 2021
- Primary completion3 Dec 2022
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricio C Ibacache, PhD, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904965
- Sponsor's protocol ID
- 200916011
- Status last verified
- Mar 2023
- First submitted
- 12 May 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20510792Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.
PubMed 21383227Anand 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.
PubMed 20403936Giordano 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.
PubMed 31609437Boncompte 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.
PubMed 40420743
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.
- ClinicalTrials.gov ID
- NCT04904965
- Acronym / sponsor ID
- 200916011
- Conditions
- Anesthesia, Surgery, Neonate, Depth of Anesthesia
- Keywords
- propofol, neonate, deph of anesthesia, Electroencephalography, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As a consequence of the cerebral immaturity of newborns (1,2), together with the fact that in the NICU it is common to find patients requiring surgery who are sedated with multiple drugs, it is necessary to define characteristic EEG patterns that allow estimation of the anesthetic depth and adequate dosage of anesthetics, avoiding the the risk of under- or overdosing of anesthetics (3).
The investigators will conduct an exploratory study. The aim of the study is to determine, by frontal electroencephalography, markers of brain electrical activity associated with the administration of propofol in term newborns requiring surgery in the NICU. A sample of 20 term neonatal patients admitted to the NICU UC with a diagnosis of surgical pathology will be included.
General objective:
To describe the characteristics of the frontal electroencephalographic pattern associated with increasing doses of propofol, in term neonates, requiring surgery in the NICU and its correlation with a clinical response, to the surgical stimulus.
Specific objectives:
- Identify the association between electroencephalographic parameters and different levels of sedation prior to surgery.
- To identify the association between electroencephalographic parameters and increasing doses (plasma concentration) of propofol administered in a previously sedated patient.
- To relate the clinical response observed to the surgical stimulus and increasing doses (plasma concentration) of propofol in a previously sedated patient (dose (concentration) - response curve).
- To describe the temporal profile of propofol anesthesia, based on the changes in electroencephalographic parameters observed over time, during the period of administration and suspension of the anesthetic.
On the scheduled day of surgery in the NICU and prior to anesthetic induction, in sedated and standardly monitored patients (ECG, SpO2, PAI, temperature, diuresis). A four-channel SedLine® monitor (Masimo Corporation, Irvine, CA, USA) will be used to monitor frontal brain electrical activity 10 minutes before the induction of anesthesia. At the end of this period, the level of sedation will be evaluated with the N-PASS clinical scale (4) and the types, doses and duration of sedative drugs administered up to that time will be recorded. Then, patients will be randomized into 4 groups, of 5 patients each, to receive manual total intravenous anesthesia, with different propofol 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/hrs. At 10 and 20 minutes after the start of the propofol infusion, arterial blood samples will be taken to determine the plasma concentration of propofol reached during the anesthetic induction. In case of hemodynamic alteration (heart rate and/or blood pressure drop by 20%) during the propofol infusion, a 25% decrease of the original dose will be performed. At the end of this period, surgery will be initiated. The hemodynamic and motor response to the surgical stimulus will be observed and recorded. If there is hemodynamic response (increase in heart rate and/or blood pressure by 20%) and/or motor response, after the surgical stimulus, fentanyl rescue 5 mcg/kg/iv will be administered. Subsequent anesthesia will be in the hands of the treating anesthesiologist in the doses and forms he/she deems convenient. Electroencephalographic tracing will be maintained continuously throughout the procedure (from 10 minutes before and up to 10 minutes after surgery). Changes and adjustments to the anesthesia and analgesia given, hemodynamic changes occurring during the procedure and anesthetic and surgical times will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Propofol Group 1 | Experimental | Drug: Propofol Group 1Patients will receive induction of anesthesia with Propofol at a rate of 2.0 mg/kg/hr. |
| Propofol Group 2 | Experimental | Drug: Propofol Group 2Patients will receive induction of anesthesia with Propofol at a rate of 4.0 mg/kg/hr. |
| Propofol Group 3 | Experimental | Drug: Propofol Group 3Patients will receive induction of anesthesia with Propofol at a rate of 6.0 mg/kg/hr. |
| Propofol Group 4 | Experimental | Drug: Propofol Group 4Patients will receive induction of anesthesia with Propofol at a rate of 8.0 mg/kg/hr. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Perinatal asphyxia
- Evidence of severe neurological injury.
- Suspected or diagnosed brain malformations
- Uncontrolled metabolic and hemodynamic instability at the time of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol Group 1Also: Group 1Propofol 2.0 mg/kg/hr per 10 min | Drug | Propofol Group 1 |
| Propofol Group 2Also: Group 2Propofol 4.0 mg/kg/hr per 10 min | Drug | Propofol Group 2 |
| Propofol Group 3Also: Group 3Propofol 6.0 mg/kg/hr per 10 min | Drug | Propofol Group 3 |
| Propofol Group 4Also: Group 4Propofol 8.0 mg/kg/hr per 10 min | Drug | Propofol Group 4 |
Primary outcome
Electroencephalography monitoring slow bands
Time frame: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency slow bands, entropy and complexity measures.
Electroencephalography monitoring alpha bands
Time frame: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency alpha bands, entropy and complexity measures.
Electroencephalography monitoring Theta bands
Time frame: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency Theta bands, entropy and complexity measures.
5 secondary outcomes
Arterial Pressure
Time frame: From induction of anesthesia until surgery starts, average 20 minutes.
Heart Rate
Time frame: From induction of anesthesia until surgery starts, average 20 minutes.
Depth of anesthesia
Time frame: before the induction of anesthesia until the surgery starts, every 10 minutes. An average of 30 minutes.
Propofol plasma concentration
Time frame: from induction of anesthesia up to 20 minutes.
Motor response to surgical incision
Time frame: at first surgical incision (average 1 minute).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 20510792Andre 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.
- Background: PubMed 21383227Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.
- Background: PubMed 20403936Anand 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.
- Background: PubMed 31609437Giordano 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.
- Derived from this study: PubMed 40420743Boncompte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio C Ibacache, PhD, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol Group 1, Propofol Group 2 and Propofol Group 3 in people with Anesthesia and Surgery, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography monitoring slow bands (time frame: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904965, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.