NCT06237101

Brief Summary

The goal of this clinical trial is to determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol in adult patients (18-60 years) candidates for elective surgery who require remifentanil and American Society of Anesthesiology (ASA) classification I or II. The main question it aims to answer are: • To determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol. Participants will undergo general anesthesia with remifentanil and propofol sequentially. After loss of consciousness, remifentanil will be adjusted to a medium or high concentration randomly and it will be determined at what concentration of propofol the burst suppressions are generated. Then, the concentrations of propofol that generate burst suppression associated with either a medium or high concentration of remifentanil will be compared.

Trial Health

77
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
4mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Mar 2024Sep 2026

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

January 24, 2024

Last Update Submit

November 17, 2025

Conditions

Anesthesia, IntravenousElectroencephalographyBurst Suppression

Outcome Measures

Primary Outcomes (1)

  • Propofol estimated concentration by Marsh pharmacological model, which generates burst suppression

    \[mcg/mL\]

    During 10 minutes when propofol dosification is increased to 15 mg/kg/h

Secondary Outcomes (5)

  • Propofol estimated concentration by Marsh pharmacological model, which generates loss of consciousness

    Minutes, during anesthesia induction is performed

  • Mean arterial pressure during burst suppression

    During 10 minutes when propofol dosification is increased to 15 mg/kg/h

  • Total ephedrine dose

    During all protocol, 40 min

  • Maximal dose of norepinephrine

    During all protocol, 40 min

  • Bispectral index at burst suppression

    During 10 minutes when propofol dosification is increased to 15 mg/kg/h

Study Arms (2)

High dose

EXPERIMENTAL

Propofol concentration which generate burst suppression at high dose of remifentanil

Drug: High dose of remifentanil

Medium dose

ACTIVE COMPARATOR

Propofol concentration which generate burst suppression at medium dose of remifentanil

Drug: Medium dose of remifentanil

Interventions

High dose of remifentanilDRUG

The dose of remifentanil will be changed to determine the concentration of propofol at which burst suppressions are generated

High dose
Medium dose of remifentanilDRUG

The dose of remifentanil will be changed to determine the concentration of propofol at which burst suppressions are generated

Medium dose

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiology I or II
  • Elective surgery of low or intermediate risk

You may not qualify if:

  • Neurological disease
  • Psychiatric disease
  • Use of psychoactive drugs or opioids
  • Altered basal state of consciousness
  • Allergy to propofol
  • Body mass index \> 35 kg/m2
  • Pre-existing renal, cardiac and/or hepatic dysfunction
  • Patient's refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

RECRUITING

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

RECRUITING

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Antonello Penna, MD, PhD

CONTACT

+56229788209apenna@uchile.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

CL(2)