Trial no.:	PACTR202607572539325	Date of Registration:	31/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Using brain and pain monitoring to improve sedation and comfort in critically ill patients: a randomized controlled trial

Official scientific title

Using brain and pain monitoring to improve sedation and comfort in critically ill patients: a randomized controlled trial

Brief summary describing the background and objectives of the trial

Sedation in critically ill patients is commonly guided by intermittent clinical scales such as the Richmond Agitation-Sedation Scale (RASS), which do not provide continuous information on cortical activity or nociceptive responsiveness. This limitation may lead to over-sedation, under-sedation, and inadequate analgesia, all of which are associated with adverse clinical outcomes. The CONOX-2D monitor provides continuous processed EEG-derived indices of hypnosis (qCON) and nociception responsiveness (qNOX), which may allow more precise titration of sedatives and analgesics. This randomized controlled trial aims to evaluate whether CONOX-guided sedation and analgesia improves the proportion of time within target sedation range compared with standard care in mechanically ventilated critically ill patients.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

CONOX-ICU Trial

Disease(s) or condition(s) being studied

Anaesthesia,Critical care / ICU sedation and analgesia management”,Mental and Behavioural Disorders,Nervous System Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

15/08/2026

Actual trial start date

Anticipated date of last follow up

15/08/2027

Actual Last follow-up date

Anticipated target sample size (number of participants)

300

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	CONOX	Continuous CONOX monitoring with real-time adjustment of sedation and analgesia based on qCON and qNOX indices	First 72 hours after randomization	Patients randomized to the intervention group will receive continuous processed EEG and nociception monitoring using the CONOX-2D device. Sedation will be titrated to maintain a target qCON range of 40–60, while analgesia will be adjusted according to qNOX values and clinical assessment. This monitoring will be used in conjunction with standard clinical scales (e.g., RASS and pain scores). Sedative and opioid dosing will be adjusted according to a predefined protocol based on qCON/qNOX values and clinical evaluation.	150
Control Group	CONVENTIONAL	Sedation and analgesia adjusted according to clinical scales (RASS, BPS) and usual ICU practice	First 72 hours after randomization	Patients randomized to the control group will receive standard ICU care. Sedation and analgesia will be managed using clinical assessment tools such as the Richmond Agitation-Sedation Scale (RASS) and validated pain scales (e.g., CPOT or BPS). No access to CONOX monitoring data will be available to guide clinical decision-making.	150	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Age ≥ 18 years ICU admission Requirement for invasive mechanical ventilation Expected need for continuous IV sedation ≥ 24 hours Use of sedative and opioid agents	Severe primary neurological injury requiring dedicated neuro-monitoring protocols (optional) Status epilepticus requiring continuous EEG Severe pre-existing neurological impairment Expected death within 24 hours Contraindication to electrode placement Pregnancy	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	100 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

03/04/2026

Ethics Committee of the Military University Hospital of Sfax Tunisia

Ethics Committee Address
Street address	City	Postal code	Country
Rocade 11, thyna	Sfax	3082	Tunisia

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Proportion of time within target sedation range (RASS / BPS target and corresponding qCON / qNOX equivalence) during the first 72 hours	At baseline, then every 4 hours during the first 72 hours after randomization.
Secondary Outcome	Total dose of sedatives Total opioid consumption Duration of mechanical ventilation Ventilator-free days at day 28 Incidence of ICU delirium (CAM-ICU) ICU length of stay	daily during ICU stay, at ICU discharge, at hospital discharge, at Day 28 and at Day 90.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Military University Hospital of Sfax	Rocade 11, Thyna	Sfax	3082	Tunisia

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Military University Hospital of Sfax	Rocade 11, thyna	Sfax	3082	Tunisia

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Military University Hospital of Sfax	Rocade 11, Thyna	Sfax	3082	Tunisia	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Scientific Enquiries	Yassine Maktouf	yassine.maktouf@gmail.com	0021629442333	Rocade 11, thyna
City	Postal code	Country	Position/Affiliation
Sfax	3082	Tunisia	Head of the departement
Role	Name	Email	Phone	Street address
Public Enquiries	Mariem Ben Abdallah	mariembenabdallah@gmail.com	0021656778931	Rocade 11, thyna
City	Postal code	Country	Position/Affiliation
Sfax	3082	Tunisia	Medical Doctor
Role	Name	Email	Phone	Street address
Principal Investigator	Karim Jarraya	karimjarraya@outlook.fr	0021653637389	Rocade 11, thyna
City	Postal code	Country	Position/Affiliation
Sfax	3082	Tunisia	Madical Resident

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	De-identified individual participant data including demographic characteristics, clinical variables, sedation and analgesia parameters, continuous qCON and qNOX monitoring data, drug exposure, and primary and secondary outcomes, as well as the study protocol and statistical analysis plan.	Informed Consent Form,Statistical Analysis Plan,Study Protocol	“Data will be available starting 6 months after publication of the primary results and will remain available for up to 5 years.	Access to data will be granted to qualified researchers upon reasonable request for scientific purposes, subject to approval by the study investigators and the institutional ethics committee, and under a data sharing agreement.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	26/07/2026	Title changed to be the same as the one in the approval letter. It used to be the public title.	CONOX-Guided Sedation and Nociception Monitoring in Critically Ill Patients: A Randomized Controlled Trial	Using brain and pain monitoring to improve sedation and comfort in critically ill patients: a randomized controlled trial
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Anticipated trial start date	26/07/2026	we're waiting for the trial approval on PACTR	15 May 2026	15 Aug 2026
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Anticipated date of last follow up	26/07/2026	we're waiting for the trial approval on PACTR	15 May 2027	15 Aug 2027
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Target no of participants	26/07/2026	150 patients per group, i made a mistake when filling the form	150	300
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	17/05/2026	Yes every group would include 150 patients		Experimental Group, CONOX, Continuous CONOX monitoring with real-time adjustment of sedation and analgesia based on qCON and qNOX indices, First 72 hours after randomization, Patients randomized to the intervention group will receive continuous processed EEG and nociception monitoring using the CONOX-2D device. Sedation will be titrated to maintain a target qCON range of 40–60, while analgesia will be adjusted according to qNOX values and clinical assessment. This monitoring will be used in conjunction with standard clinical scales (e.g., RASS and pain scores). Sedative and opioid dosing will be adjusted according to a predefined protocol based on qCON/qNOX values and clinical evaluation., 150,

Pan African Clinical Trials Registry