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Recruiting NCT06822660

Dreams or Implicite Memorization Under OFA

Observational Implicite Memorization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Implicite Memorization. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Implicite memorization incidence [Time frame: From the operating room to one week after surgery]
Secondary outcome measures (1)
  • explicite memorization [Time frame: From the operating room to one week after surgery]

Eligibility criteria

Inclusion criteria

  • laparoscopic robotic surgery
  • ASA score 1 to 3

Exclusion criteria

  • neurological and psychiatric diseases
  • reflect memory disorders
  • head trauma
  • hearing disorders
  • past or current use of medications affecting the central nervous system.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • CHU Saint Pierre — Brussels

Identifiers

NCT: NCT06822660 · B0762024241010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗