TachycardiaPhase 4NCT01259648
Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
A Phase 4 study testing 0.5 µg/kg remifentanil, 1.0 µg/kg remifentanil and NaCl in people with Tachycardia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Tachycardia
- What is being tested?
- 0.5 µg/kg remifentanil, 1.0 µg/kg remifentanil and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Mar 2011to 20 May 2014
- Phase
- Phase 4
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
- Patient able to give informed consent, and sign the consent.
Who cannot join
- Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
- Morbid obesity (Body Mass Index > 40)
- Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
- Inclusion in another research project within the past 3 months
- The patient is not insured or beneficiary of a health insurance plan (for the French centers)
- Patient under guardianship of any kind
- Patient unable to give informed consent
- Refusal to sign the consent form
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
Polyclinique Grand Sud
Nîmes, Gard, 30029
About this study
Official title: Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.
- Conditions
- Tachycardia
- Being tested
- 0.5 µg/kg remifentanil, 1.0 µg/kg remifentanil, NaCl
- Keywords
- remifentanil, anesthesia induction, reactional tachycardia
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 µg/kg remifentanilDrug
0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
1.0 µg/kg remifentanilDrug
1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
NaClDrug
an equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol
| Study group | Role | What they receive |
|---|---|---|
| 0.5 µg / kg remifentanil | Experimental | Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol. Receives: Drug: 0.5 µg/kg remifentanil |
| 1.0 µg/kg remifentanil | Experimental | Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol. Receives: Drug: 1.0 µg/kg remifentanil |
| NaCl | Placebo comparator | An equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac frequency (beats per minute)
Patient cardiac frequency (beats per minute) at the time of induction
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study start9 Mar 2011
- Primary completion20 May 2014
- Study completion20 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Chaumeron, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259648
- Sponsor's protocol ID
- LOCAL/2009/AC-02
- Other IDs
- 2009-018169-12, 2009
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data available upon request.
Publications
Chaumeron A, Castanie J, Fortier LP, Basset P, Bastide S, Alonso S, Lefrant JY, Cuvillon P. Efficacy and safety of remifentanil in a rapid sequence induction in elderly patients: A three-arm parallel, double blind, randomised controlled trial. Anaesth Crit Care Pain Med. 2020 Apr;39(2):215-220. doi: 10.1016/j.accpm.2019.09.010. Epub 2019 Oct 12.
PubMed 31614244
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
- ClinicalTrials.gov ID
- NCT01259648
- Acronym / sponsor ID
- LOCAL/2009/AC-02
- Conditions
- Tachycardia
- Keywords
- remifentanil, anesthesia induction, reactional tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 9 Mar 2011 (actual)
- Primary completion
- 20 May 2014 (actual)
- Study completion
- 20 May 2014 (actual)
- First posted
- 14 Dec 2010 (estimated)
- 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 primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5 µg / kg remifentanil | Experimental | Drug: 0.5 µg/kg remifentanilInduction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol. |
| 1.0 µg/kg remifentanil | Experimental | Drug: 1.0 µg/kg remifentanilInduction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol. |
| NaCl | Placebo comparator | Drug: NaClAn equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
- Patient able to give informed consent, and sign the consent.
Key exclusion criteria (8 listed)
- Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
- Morbid obesity (Body Mass Index > 40)
- Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
- Inclusion in another research project within the past 3 months
- The patient is not insured or beneficiary of a health insurance plan (for the French centers)
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 |
|---|---|---|
| 0.5 µg/kg remifentanil0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol | Drug | 0.5 µg / kg remifentanil |
| 1.0 µg/kg remifentanil1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol | Drug | 1.0 µg/kg remifentanil |
| NaClan equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol | Drug | NaCl |
Primary outcome
Cardiac frequency (beats per minute)
Time frame: 15 minutes
Patient cardiac frequency (beats per minute) at the time of induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 31614244Chaumeron A, Castanie J, Fortier LP, Basset P, Bastide S, Alonso S, Lefrant JY, Cuvillon P. Efficacy and safety of remifentanil in a rapid sequence induction in elderly patients: A three-arm parallel, double blind, randomised controlled trial. Anaesth Crit Care Pain Med. 2020 Apr;39(2):215-220. doi: 10.1016/j.accpm.2019.09.010. Epub 2019 Oct 12.
- Individual participant dataSharing planned: Yes. Data available upon request.
Related trials for Tachycardia
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Assessment of Combined CCM and ICD Device in HFrEF
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HEAL-IST IDE Trial
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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.
Arnaud Chaumeron, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5 µg/kg remifentanil, 1.0 µg/kg remifentanil and NaCl in people with Tachycardia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac frequency (beats per minute) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259648, which also lists 1 linked publication.
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 17 Nov 2025.