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Impact of Opioids on Heart Rate During Rapid Sequence Intubation

NCT05384665 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-26

No results posted yet for this study

Summary

The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.

Patients will be divided into 3 parallel groups :

* Group A (placebo +remifentanil)
* Group B (sufentanil + placebo)
* Group C (placebo + placebo)

Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.

To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.

The MAR injects the drugs according to the standardized study plan (see below):

* T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1
* 3 minute delay
* Patient receives Etomidate 0.3 mg/kg IV over 10 seconds
* 5 second delay
* The patient receives an IV bolus over 30 seconds of molecule n°2
* 5 second delay
* The patient receives Succinylcholine or Rocuronium IV over 5 seconds
* T2: End of induction, oro-tracheal intubation (= T2)

The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).

Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.

Conditions

  • Rapid Sequence Induction

Interventions

DRUG

Remifentanil

REMIFENTANIL, 5 µg/cc, solution for injection, 0.5 µg/kg, parenteral (intravenous) route, injection delay of 30 seconds, once only

DRUG

Sufentanil

SUFENTANIL, 5 µg/cc, solution for injection, 0.2 µg/kg, parenteral (intravenous) route, bolus over 5 seconds, once

DRUG

Placebo

PLACEBO contains 0.9% NaCl, parenteral (intravenous), bolus, one-time

Sponsors & Collaborators

  • Centre Hospitalier Sud Francilien

    lead OTHER

Principal Investigators

  • Marine FONTAINE, MD · Centre Hospitalier Sud Francilien

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2023-10-18
Completion
2023-10-18

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384665 on ClinicalTrials.gov