NCT04466384 (SONORA) is a NA clinical trial of BIS in Anesthesia, sponsored by Medtronic - MITG.

Who is sponsoring NCT04466384?

NCT04466384 is sponsored by Medtronic - MITG.

What drugs are being tested in NCT04466384?

Interventions in NCT04466384: BIS.

What condition does NCT04466384 study?

NCT04466384 studies Anesthesia.

Is NCT04466384 still recruiting?

NCT04466384 is currently completed. Last updated 19 July 2022.

Are results published for NCT04466384?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-19 · How we verify

NCT04466384: SONORA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)

Completed NA Results posted Last updated 19 July 2022

What this trial tests

NA trial testing BIS in Anesthesia in 34 participants. Completed in 3 March 2021.

Timeline

11 August 2020

Primary endpoint
3 March 2021

3 March 2021

Quick facts

Lead sponsor	Medtronic - MITG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	34
Start date	11 August 2020
Primary completion	3 March 2021
Estimated completion	3 March 2021
Sites	1 location across United States

Drugs / interventions tested

Conditions studied

Anesthesia — all drugs for Anesthesia →

Sponsor

Medtronic - MITG — full company profile →

Who can join

Adults 18 to 60, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

BIS50 Primary · 4 hours

To determine BIS50 (BIS™ value at which 50% of patients will be unresponsive at given drug concentrations) and other dose-response parameters. BIS™ is a scale 0-100 with values near 100 represent an "awake" clinical state while 0 denotes the maximal EEG effect possible (i.e., an isoelectric EEG). Responsiveness is measured using the Modified Observer's Assessment of Alertness/ Sedation (MOAA/S). Below a MOAA/S of 2, responsiveness is measured with Tetanic Electrical Stimulation (TES). The subject will receive one stimulation of 50mA, 50 Hz for 5 seconds. Their response, such as withdrawal of t

Group	Value	95% CI
Propofol	60.4	57.7 – 63.0
Propofol With Remifentanil	71.6	69.0 – 74.6

BIS95 Secondary · 4 hours

To determine BIS95 (BIS™ value at which 95% of patients will be unresponsive at given drug concentrations) and other dose-response parameters. BIS™ is a scale 0-100 with values near 100 represent an "awake" clinical state while 0 denotes the maximal EEG effect possible (i.e., an isoelectric EEG). Responsiveness is measured using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S). Below a MOAA/S of 2, responsiveness is measured with Tetanic Electrical Stimulation (TES). The subject will receive one stimulation of 50mA, 50 Hz for 5 seconds. Their response, such as withdrawal of th

Group	Value	95% CI
Propofol	47.7	40.5 – 51.7
Propofol With Remifentanil	63.1	57.3 – 66.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Propofol First (First Phase)

Serious: 0/14 (0%)

Deaths: 0/14

First Propofol With Remifentanil (First Phase)

Serious: 0/10 (0%)

Deaths: 0/10

Propofol First (Cross Over Phase)

Serious: 0/14 (0%)

Deaths: 0/14

First Propofol With Remifentanil (Cross Over Phase)

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (6 terms — click to expand)

Reaction	System	Propofol First (First Phase)	First Propofol With Remife…	Propofol First (Cross Over…	First Propofol With Remife…
Headache	Nervous system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04466384 adverse events section.

Sponsor's own description

The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Non-contact (touchless) monitoring of respiratory rate in a challenging anesthesia setting using a depth camera.
MacLeod DB, Smit P, Antunes A, Montgomery D, et al · · 2026 · PMID 40637989 · DOI 10.1007/s10877-025-01319-6

Verify or expand the search:

Other trials of BIS

Trials testing the same drug.

NCT06177847 — Efficacy of BIS Monitoring in Deep Hypnotic State · NA · unknown
NCT05148065 — Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old · completed
NCT04736303 — The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium · NA · unknown
NCT03704285 — Development of pk/pd Model of Propofol in Patients With Severe Burns · terminated
NCT03738137 — Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy · NA · completed

Other recruiting trials for Anesthesia

Currently open trials in the same condition.

NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
NCT07465185 — Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery · Phase 2 · recruiting
NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting

Other Medtronic - MITG trials

Trials by the same sponsor.

NCT07351071 — Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Res · NA · recruiting
NCT07166341 — Accuracy Verification of the INVOS PM7100 · active not recruiting
NCT07201961 — Nellcor™ Abbreviated Sensor Additional Data Collection · completed
NCT06710795 — AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair · NA · active not recruiting
NCT06638073 — Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department o · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04466384 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic - MITG
Last refreshed: 19 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04466384.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing