Who is sponsoring NCT02884310?

NCT02884310 is sponsored by Erasme University Hospital.

What condition does NCT02884310 study?

NCT02884310 studies Intravenous Anesthetic Agent Overdose.

What drugs are being tested in NCT02884310?

Interventions: Remifentanil adapted to SPI, Remifentanil fixed.

What is the status of NCT02884310?

NCT02884310 is currently COMPLETED.

Last reviewed 2017-08-17 · How we verify

Interest of the Gradient of Nociceptive Indexes After a Tetanus (100 Hz, 60 Milliamperes, 30 Seconds) at a Fixed Remifentanil Effect Site Concentration to Adjust Remifentanil Before Tracheal Intubation and Skin Incision

NCT02884310 Phase 4 COMPLETED

Individually-tailored administration of the opioid analgesic component during general anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to look if the gradient response of a nociception index to a calibrated tetanic stimulus during standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal intubation and before skin incision. The studied parameters are the SPI index developed by General Electric, the "Analgesia Nociception Index" and the pupil dilation using the pupil scan algometer.

Details

Lead sponsor	Erasme University Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	48
Start date	2013-01
Completion	2016-05

Conditions

Intravenous Anesthetic Agent Overdose

Interventions

Remifentanil adapted to SPI
Remifentanil fixed

Primary outcomes

hemodynamic stability following tracheal intubation and surgical incision — within 60 minutes after anesthesia induction
Improvement of hemodynamic stability at anesthesia induction if remifentanil analgesia is not fixed at a predefined value for all patients but adapted to a nociceptive test at a predefined remifentanil concentration