Impact of Opioids on Heart Rate During Rapid Sequence Intubation

NCT ID: NCT05384665

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2023-10-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group A (placebo + remifentanil)

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Group B (sufentanil + placebo)

Group Type: EXPERIMENTAL

Sufentanil

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Group C (placebo + placebo)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Remifentanil

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

Intervention Type: DRUG

Sufentanil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marine FONTAINE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

EUCT 2022-500369-28-00

Identifier Type: -

Identifier Source: org_study_id