Impact of Opioids on Heart Rate During Rapid Sequence Intubation

NCT05384665 | Terminated

• 1 other identifier: EUCT 2022-500369-28-00
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• heart rate beats per minute

  Absolute variation of heart rate beats per minute between T0 (reference value at the entrance into the operating room) and T2 (end of induction and oro-tracheal intubation)

  T2 : oro-tracheal induction

Secondary Outcomes (10)

• Cormack score

  T2 : oro-tracheal induction

• Laryngoscopy of Macintosh number

  T2 : oro-tracheal induction

• Use of a long bent mandrel

  T2 : oro-tracheal induction

• assess side effects according to the opioids used

  T2 : oro-tracheal induction

• assess side effects according to the opioids used

  before T2 : oro-tracheal induction

Study Arms (3)

Group A (placebo + remifentanil)

EXPERIMENTAL

Drug: Remifentanil; Drug: Placebo

Group B (sufentanil + placebo)

EXPERIMENTAL

Drug: Sufentanil; Drug: Placebo

Group C (placebo + placebo)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Remifentanil DRUG

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

Group A (placebo + remifentanil)

Sufentanil DRUG

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

Group B (sufentanil + placebo)

Placebo DRUG

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

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 65 years old and any possible ASA OR Patient aged 55 to 65 years old with an ASA ≥ 3,
• Patient undergoing surgery (urgent or scheduled), requiring general anesthesia in rapid sequence, because considered to have a "full stomach", i.e. with: gastro-oesophageal pathology or gastroparesis or a history of bariatric surgery or food intake within two hours for liquids and within six hours for solids,
• Patient informed of the study who gave their written consent before starting the study procedures,
• Patient affiliated to a French social security system.

You may not qualify if:

• Patient \< 55 years old,
• Patient on beta blockers,
• Atrial fibrillation or other rhythm or conduction disturbances,
• Patient in hemodynamic failure and/or on catecholamines before the start of GA,
• Patient having a history of stroke, hemorrhagic and/or ischemic and/or transient
• Combination with opioid agonists-antagonists or partial opioid antagonists
• Known hypersensitivity to one of the study drugs or to opioids,
• History of difficult intubation,
• Patient under guardianship, curatorship or deprived of liberty,
• Patient participating in another interventional clinical research,
• Patient under AME (State Medical Aid)

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Interventions

Remifentanil; Sufentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl

Study Officials

• Marine FONTAINE, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized controlled study

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: May 16, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)