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Recruiting

NCT Number: NCT06822660

Dreams or Implicite Memorization Under OFA

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint Pierre

Brussels, 1000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. explicite memorization

    Time frame: From the operating room to one week after surgery

    Through the modified brice questionnaire, we assess the incidence of explicite memorization

Study contacts

Contact information is provided by the study sponsor or research team.

Florent Postal, Md

CONTACT

[email protected]

+32 470 044 986

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Acronym: Dreams

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.