Interest of a Tetanus Test at a Fixed Remifentanil Concentration Before Laryngoscopy and Skin Incision
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|ClinicalTrials.gov Identifier: NCT02884310|
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intravenous Anesthetic Agent Overdose||Drug: Remifentanil adapted to SPI Drug: Remifentanil fixed||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2016|
Experimental: SPI group
Remifentanil titration before tracheal intubation and skin incision according to the SPI gradient obtained after a nociceptive test using a tetanic stimulus of 100 Hz, 60 milliamperes during 30 seconds performed at a 3 ng/ml level of the remifentanil concentration.
During surgery, the effect site remifentanil concentration was either increased or decreased by 1 ng/ml to maintain SPI below 40 or above 20, respectively.
Drug: Remifentanil adapted to SPI
Active Comparator: Control group
The remifentanil concentration before tracheal intubation and skin incision was fixed at 4 ng/ml.
During surgery, the remifentanil concentration was adapted according to the hemodynamic answer of the patient. It was changed by 1 ng/ml stepwise variations to maintain heart rate and mean blood pressure within 20% of the patient reference hemodynamic values.
Drug: Remifentanil fixed
- hemodynamic stability following tracheal intubation and surgical incision [ Time Frame: 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
- hemodynamic stability during surgery [ Time Frame: within surgery ]Improvement of hemodynamic stability during surgery if remifentanil is adapted to SPI changes