Interest of a Tetanus Test at a Fixed Remifentanil Concentration Before Laryngoscopy and Skin Incision

NCT02884310 | Completed Phase 4

• 1 other identifier: ErasmeUH P2012/20
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intravenous Anesthetic Agent Overdose

Keywords

Remifentanil; Heart Rate Variability; Pupil dilation; SPI

Outcome Measures

Primary Outcomes (1)

• hemodynamic stability following tracheal intubation and surgical incision

  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

  within 60 minutes after anesthesia induction

Secondary Outcomes (1)

• hemodynamic stability during surgery

  within surgery

Study Arms (2)

SPI group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Remifentanil adapted to SPI DRUG

SPI group

Remifentanil fixed DRUG

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead
• University of Liege: collaborator

Related Publications (1)

• Defresne A, Barvais L, Clement F, Bonhomme V. Standardised noxious stimulation-guided individual adjustment of remifentanil target-controlled infusion to prevent haemodynamic responses to laryngoscopy and surgical incision: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):173-183. doi: 10.1097/EJA.0000000000000742.

  PMID: 29189318 DERIVED

MeSH Terms

Conditions

Mydriasis

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and head of the cardiothoracic and vascular anesthesia Clinics

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 31, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share