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Trial record 1 of 2 for:    "Tetanus" | "tannic acid"
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Interest of a Tetanus Test at a Fixed Remifentanil Concentration Before Laryngoscopy and Skin Incision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02884310
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : August 22, 2017
University of Liege
Information provided by (Responsible Party):
Luc Barvais, Erasme University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intravenous Anesthetic Agent Overdose Drug: Remifentanil adapted to SPI Drug: Remifentanil fixed Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. hemodynamic stability during surgery [ Time Frame: within surgery ]
    Improvement of hemodynamic stability during surgery if remifentanil is adapted to SPI changes

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 18 years
  • Informed consent obtained during the pre-anesthetic visit
  • American Society Anesthesiology status I or II
  • Scheduled surgery under general anesthesia, and necessitating endotracheal intubation and controlled mechanical ventilation
  • Body mass index (BMI) between 17 and 30 kg/m2

Exclusion Criteria:

  • Pregnancy
  • Patient refusal
  • Pace maker (all modes)
  • Heart failure

    • Ejection fraction < 50%
    • Symptomatic aortic or mitral pathology
  • Non sinus rhythm
  • Chronic use of beta blocking agents or other anti-hypertensive medications, except for diuretics
  • Dysautonomia
  • Diabetes
  • Spontaneous ventilation during anesthesia
  • Allergy to one of the medications used during this experiment

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics, Erasme University Hospital Identifier: NCT02884310     History of Changes
Other Study ID Numbers: ErasmeUH P2012/20
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Luc Barvais, Erasme University Hospital:
Heart Rate Variability
Pupil dilation
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents