Dreams or Implicite Memorization Under OFA

NCT06822660 | Recruiting DMC

• 1 other identifier: B0762024241010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Implicite Memorization

Keywords

implicite memorization; opioid free anesthesia; observationnal; monocentric; isolated forearm technique; explicite memorization

Outcome Measures

Primary Outcomes (1)

• 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

  From the operating room to one week after surgery

Secondary Outcomes (1)

• explicite memorization

  From the operating room to one week after surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We study patients 18-75 aged undergoing laparoscopic robotic surgery ( prostatectomy, hysterectomy, colectomy) with an ASA status from 1 to 3.

You may qualify if:

• laparoscopic robotic surgery
• ASA score 1 to 3

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

RECRUITING

Central Study Contacts

Florent Postal, Md

CONTACT

+32 470 044 986; florent.postal@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: November 25, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 15, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

BE (1)