Impact of Opioids on Heart Rate During Rapid Sequence Intubation

Not Applicable

Terminated

• Conditions: Rapid Sequence Induction
• Interventions: Drug: Remifentanil; Drug: Sufentanil; Drug: Placebo

• Registration Number: NCT05384665
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-20
• Study Start: 2023-05-16
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (sufentanil + placebo)	Placebo	-
Group A (placebo + remifentanil)	Remifentanil	-
Group A (placebo + remifentanil)	Placebo	-
Group B (sufentanil + placebo)	Sufentanil	-
Group C (placebo + placebo)	Placebo	-

Primary Outcome Measures

Name	Time	Method
heart rate beats per minute	T2 : oro-tracheal induction	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)

Secondary Outcome Measures

Name	Time	Method
assess significant variation in hemodynamic responses	T13 (10 minutes after intubation)	Absolute and relative variations of +/- 20% of HR between T0 and T13.
Cormack score	T2 : oro-tracheal induction	Cormack score in each group
Laryngoscopy of Macintosh number	T2 : oro-tracheal induction	Laryngoscopy number for each group
Use of a long bent mandrel	T2 : oro-tracheal induction	Use of a long bent mandrel for each group
assess side effects according to the opioids used	T2 : oro-tracheal induction	Percentage of patients with thoracic rigidity and/or bradycardia \< 50/min at T2 for each group

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France