CClinicalTrials.gg
Sign In
TerminatedNCT05384665CANDY-CRASHUpdated May 26, 2026

Impact of Opioids on Heart Rate During Rapid Sequence Intubation

An interventional study of Remifentanil and Sufentanil in Rapid Sequence Induction, sponsored by Centre Hospitalier Sud Francilien. Terminated at 1 site in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Centre Hospitalier Sud Francilien · Not applicable, Interventional, and Other

Why this study was terminated
rate of inclusion too low
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rapid Sequence Induction
03

In context

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 57 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Group A (placebo + remifentanil)

    Drug: Remifentanil · Drug: Placebo

  • Experimental
    Group B (sufentanil + placebo)

    Drug: Sufentanil · Drug: Placebo

  • Placebo comparator
    Group C (placebo + placebo)

    Drug: Placebo

Interventions

  • DrugRemifentanil

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

  • DrugSufentanil

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

  • DrugPlacebo

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

06

What researchers measure

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)

    Time frame: T2 : oro-tracheal induction

Secondary outcomes

  1. Cormack score

    Cormack score in each group

    Time frame: T2 : oro-tracheal induction

  2. Laryngoscopy of Macintosh number

    Laryngoscopy number for each group

    Time frame: T2 : oro-tracheal induction

  3. Use of a long bent mandrel

    Use of a long bent mandrel for each group

    Time frame: T2 : oro-tracheal induction

  4. assess side effects according to the opioids used

    Percentage of patients with intraoperative vomiting at T2 for each group

    Time frame: T2 : oro-tracheal induction

  5. assess side effects according to the opioids used

    Percentage of patients requiring vasopressor before T2

    Time frame: before T2 : oro-tracheal induction

  6. assess side effects according to the opioids used

    Percentage of patients with thoracic rigidity and/or bradycardia \< 50/min at T2 for each group

    Time frame: T2 : oro-tracheal induction

  7. assess significant variation in hemodynamic responses

    Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2

    Time frame: T2 : oro-tracheal induction

  8. assess significant variation in hemodynamic responses

    Absolute and relative variations of +/- 20% in SAP/DA and MAP between T0 and T13

    Time frame: T13 (10 minutes after intubation)

  9. assess significant variation in hemodynamic responses

    Relative variation of +/- 20% of HR between T0 and T2

    Time frame: T2 : oro-tracheal induction

  10. assess significant variation in hemodynamic responses

    Absolute and relative variations of +/- 20% of HR between T0 and T13.

    Time frame: T13 (10 minutes after intubation)

07

Study locations

1 site
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, France 91106, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05384665
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
May 20, 2022
Start date
May 16, 2023
Primary completion
Oct 18, 2023
Completion
Oct 18, 2023
Last update
May 26, 2026

Study contacts

Marine FONTAINE, MD
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Centre Hospitalier Sud Francilien

Start the discussion