Implicite MemorizationDreamsNCT06822660
Dreams or Implicite Memorization Under OFA
An observational study of Implicite Memorization, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The Dreams study is an observational study aimed at evaluating the incidence of connected awareness after intubation, intraoperative explicit and implicit memorization, and postoperative well-being in patients receiving general anesthesia without opioids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Implicite Memorization
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Nov 2024to 15 Jun 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We study patients 18-75 aged undergoing laparoscopic robotic surgery ( prostatectomy, hysterectomy, colectomy) with an ASA status from 1 to 3.
Who may be able to join
- laparoscopic robotic surgery
- ASA score 1 to 3
Who cannot join
- neurological and psychiatric diseases
- reflect memory disorders
- head trauma
- hearing disorders
- past or current use of medications affecting the central nervous system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The Dreams study is an observational study aimed at evaluating the incidence of connected awareness after intubation, intraoperative explicit and implicit memorization, and postoperative well-being in patients receiving general anesthesia without opioids.
Outcomes
Read more
The primary objective is the evaluation of the incidence of connected consciousness after induction of general anesthesia without opioids and intubation. The secondary objectives are:
- Implicit and explicit memorization after intubation and during the procedure
- Post-operative well-being Pain in the recovery room and in the room, assessed by VAS;
- Total consumption of analgesics (paracetamol, diclofenac, tramadol): data collected during discharge
- Level of satisfaction, assessed using the EVAN scale
- Duration of hospitalization
- Estimated first mobilization
- Conditions
- Implicite Memorization
- Keywords
- implicite memorization, opioid free anesthesia, observationnal, monocentric, isolated forearm technique, explicite memorization
What is being measured
The primary outcome is the main question the study is designed to answer.
Implicite memorization incidence
Through the isolated forearm technique and with the capacity of patients to recognize post operatively sounds that they have listened during the anesthesia, we evaluate the incidence of implicite memorization
Measured: From the operating room to one week after surgery
Secondary outcomes (1)
explicite memorization
Through the modified brice questionnaire, we assess the incidence of explicite memorization
Measured: From the operating room to one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start25 Nov 2024
- Primary completionJun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implicite MemorizationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822660
- Sponsor's protocol ID
- B0762024241010
- Acronym
- Dreams
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dreams or Implicite Memorization Under OFA
- ClinicalTrials.gov ID
- NCT06822660
- Acronym / sponsor ID
- Dreams / B0762024241010
- Conditions
- Implicite Memorization
- Keywords
- implicite memorization, opioid free anesthesia, observationnal, monocentric, isolated forearm technique, explicite memorization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
The Dreams study is an observational study aimed at evaluating the incidence of connected awareness after intubation, intraoperative explicit and implicit memorization, and postoperative well-being in patients receiving general anesthesia without opioids.
Outcomes
The primary objective is the evaluation of the incidence of connected consciousness after induction of general anesthesia without opioids and intubation. The secondary objectives are:
- Implicit and explicit memorization after intubation and during the procedure
- Post-operative well-being Pain in the recovery room and in the room, assessed by VAS;
- Total consumption of analgesics (paracetamol, diclofenac, tramadol): data collected during discharge
- Level of satisfaction, assessed using the EVAN scale
- Duration of hospitalization
- Estimated first mobilization
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We study patients 18-75 aged undergoing laparoscopic robotic surgery ( prostatectomy, hysterectomy, colectomy) with an ASA status from 1 to 3.
Key inclusion criteria (2 listed)
- laparoscopic robotic surgery
- ASA score 1 to 3
Key exclusion criteria (5 listed)
- neurological and psychiatric diseases
- reflect memory disorders
- head trauma
- hearing disorders
- past or current use of medications affecting the central nervous system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implicite memorization incidence
Time frame: From the operating room to one week after surgery
Through the isolated forearm technique and with the capacity of patients to recognize post operatively sounds that they have listened during the anesthesia, we evaluate the incidence of implicite memorization
1 secondary outcome
explicite memorization
Time frame: From the operating room to one week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implicite Memorization, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent Postal, Md (+32 470 044 986, florent.postal@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implicite memorization incidence (time frame: From the operating room to one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.