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TERMINATED
NCT05384665
NA

Impact of Opioids on Heart Rate During Rapid Sequence Intubation

Sponsor: Centre Hospitalier Sud Francilien

View on ClinicalTrials.gov

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.

Official title: Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2023-05-16

Completion Date

2023-10-18

Last Updated

2026-05-26

Healthy Volunteers

No

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

Locations (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, France