Impact of Opioids on Heart Rate During Rapid Sequence Intubation — CANDY-CRASH  

Rapid Sequence Induction Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Rapid Sequence Induction

• NCT number: NCT05384665
• Study type: Interventional
• Source: Centre Hospitalier Sud Francilien
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2023
• Completion date: October 18, 2023