Heart rate drug study halted after just 3 patients
NCT ID NCT05384665
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see how different opioids change heart rate during rapid-sequence intubation, a procedure for patients with a full stomach needing emergency anesthesia. Researchers planned to compare two opioids (remifentanil and sufentanil) against a placebo in older or high-risk surgical patients. However, the study was stopped early after enrolling only 3 participants, so no meaningful conclusions can be drawn.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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May 2023
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106, France
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