Clinical trial NCT05384665: Impact of Opioids on Heart Rate During Rapid Sequence Intubation
Official title: Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rapid Sequence Induction
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 3
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized controlled study
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: heart rate beats per minute
timeFrame: T2 : oro-tracheal induction
Secondary outcomes:
measure: Cormack score
timeFrame: T2 : oro-tracheal induction
measure: Laryngoscopy of Macintosh number
timeFrame: T2 : oro-tracheal induction
measure: Use of a long bent mandrel
timeFrame: T2 : oro-tracheal induction
measure: assess side effects according to the opioids used
timeFrame: T2 : oro-tracheal induction
measure: assess side effects according to the opioids used
timeFrame: before T2 : oro-tracheal induction
measure: assess side effects according to the opioids used
timeFrame: T2 : oro-tracheal induction
measure: assess significant variation in hemodynamic responses
timeFrame: T2 : oro-tracheal induction
measure: assess significant variation in hemodynamic responses
timeFrame: T13 (10 minutes after intubation)
measure: assess significant variation in hemodynamic responses
timeFrame: T2 : oro-tracheal induction
measure: assess significant variation in hemodynamic responses
timeFrame: T13 (10 minutes after intubation)
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Marine FONTAINE, MD
role: PRINCIPAL_INVESTIGATOR
References: