Rapid Sequence InductionCANDY-CRASHNCT05384665
Impact of Opioids on Heart Rate During Rapid Sequence Intubation
A study testing Remifentanil and Sufentanil in people with Rapid Sequence Induction, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- Remifentanil and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2023to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study
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 :
Read more
- 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
- Being tested
- Remifentanil, Sufentanil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
REMIFENTANIL, 5 µg/cc, solution for injection, 0.5 µg/kg, parenteral (intravenous) route, injection delay of 30 seconds, once only
SufentanilDrug
SUFENTANIL, 5 µg/cc, solution for injection, 0.2 µg/kg, parenteral (intravenous) route, bolus over 5 seconds, once
PlaceboDrug
PLACEBO contains 0.9% NaCl, parenteral (intravenous), bolus, one-time
| Study group | Role | What they receive |
|---|---|---|
| Group A (placebo + remifentanil) | Experimental | Not described Receives: Drug: Remifentanil; Drug: Placebo |
| Group B (sufentanil + placebo) | Experimental | Not described Receives: Drug: Sufentanil; Drug: Placebo |
| Group C (placebo + placebo) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: T2 : oro-tracheal induction
Secondary outcomes (10)
Cormack score
Cormack score in each group
Measured: T2 : oro-tracheal induction
Laryngoscopy of Macintosh number
Laryngoscopy number for each group
Measured: T2 : oro-tracheal induction
Use of a long bent mandrel
Use of a long bent mandrel for each group
Measured: T2 : oro-tracheal induction
assess side effects according to the opioids used
Percentage of patients with intraoperative vomiting at T2 for each group
Measured: T2 : oro-tracheal induction
assess side effects according to the opioids used
Percentage of patients requiring vasopressor before T2
Measured: before T2 : oro-tracheal induction
assess side effects according to the opioids used
Percentage of patients with thoracic rigidity and/or bradycardia < 50/min at T2 for each group
Measured: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2
Measured: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Absolute and relative variations of +/- 20% in SAP/DA and MAP between T0 and T13
Measured: T13 (10 minutes after intubation)
assess significant variation in hemodynamic responses
Relative variation of +/- 20% of HR between T0 and T2
Measured: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Absolute and relative variations of +/- 20% of HR between T0 and T13.
Measured: T13 (10 minutes after intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start16 May 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: rate of inclusion too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine FONTAINE, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384665
- Sponsor's protocol ID
- 2022-501500-10-00
- Acronym
- CANDY-CRASH
- Status last verified
- May 2026
- First submitted
- 17 May 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05384665
- Acronym / sponsor ID
- CANDY-CRASH / 2022-501500-10-00
- Conditions
- Rapid Sequence Induction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: rate of inclusion too low
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group A (placebo + remifentanil) | Experimental | Drug: Remifentanil, Drug: Placebo |
| Group B (sufentanil + placebo) | Experimental | Drug: Sufentanil, Drug: Placebo |
| Group C (placebo + placebo) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilREMIFENTANIL, 5 µg/cc, solution for injection, 0.5 µg/kg, parenteral (intravenous) route, injection delay of 30 seconds, once only | Drug | Group A (placebo + remifentanil) |
| SufentanilSUFENTANIL, 5 µg/cc, solution for injection, 0.2 µg/kg, parenteral (intravenous) route, bolus over 5 seconds, once | Drug | Group B (sufentanil + placebo) |
| PlaceboPLACEBO contains 0.9% NaCl, parenteral (intravenous), bolus, one-time | Drug | Group A (placebo + remifentanil), Group B (sufentanil + placebo), Group C (placebo + placebo) |
Primary outcome
heart rate beats per minute
Time frame: 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)
10 secondary outcomes
Cormack score
Time frame: T2 : oro-tracheal induction
Laryngoscopy of Macintosh number
Time frame: T2 : oro-tracheal induction
Use of a long bent mandrel
Time frame: T2 : oro-tracheal induction
assess side effects according to the opioids used
Time frame: T2 : oro-tracheal induction
assess side effects according to the opioids used
Time frame: before T2 : oro-tracheal induction
assess side effects according to the opioids used
Time frame: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Time frame: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Time frame: T13 (10 minutes after intubation)
assess significant variation in hemodynamic responses
Time frame: T2 : oro-tracheal induction
assess significant variation in hemodynamic responses
Time frame: T13 (10 minutes after intubation)
Results and safety
The study was stopped early (reason given: rate of inclusion too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marine FONTAINE, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and Sufentanil in people with Rapid Sequence Induction, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: rate of inclusion too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate beats per minute (time frame: T2 : oro-tracheal induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.