TerminatedNot Applicable

Impact of Opioids on Heart Rate During Rapid Sequence Intubation

Stopped: rate of inclusion too low

France3 participantsStarted 2023-05-16

Plain-language 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.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

heart rate beats per minute

Timeframe: T2 : oro-tracheal induction

Trial details

NCT IDNCT05384665

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-18

View on ClinicalTrials.gov More Rapid Sequence Induction trials