Pain Assessment During Rapid Sequence Induction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Princesse Grace
About this trial
Rapid sequence induction (RSI) is a standard anesthesia technique used in patients at risk of aspiration. Although tracheal intubation following RSI is a frequent and painful procedure, no study has yet evaluated nociception using the Analgesia Nociception Index (ANI) during this procedure.
This monocentric prospective observational study aims to describe the impact of RSI on pain measured by ANI, and to explore early complications (desaturation, hypotension, regurgitation) and factors associated with pain and complications. 150 patients undergoing RSI in the visceral surgery operating room at CHPG Monaco will be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Patient requiring tracheal intubation after rapid sequence induction in the visceral surgery operating room
Pain monitoring by Analgesia Nociception Index (ANI) as part of general anesthesia
Disqualifiers
Patient with atrial fibrillation at the time of intubation following rapid sequence induction
Patient on long-term beta-blocker therapy
Trial population
Patient requiring tracheal intubation after rapid sequence induction
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionStandard rapid sequence induction according to SFAR guidelines, with additional non-invasive ANI monitoring via cutaneous pectoral electrodes. No intervention beyond routine care; induction drug choice (hypnotic, opioid, neuromuscular blocker) at the discretion of the anesthesiologist.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation
Time frame
5 minutes post-inductionSecondary outcomes
1
Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI
Time frame
5 minutes post-induction2
Occurrence of regurgitation during RSI
Time frame
5 minutes post-induction3
First-attempt intubation success rate
Time frame
At time of intubation4
Variation of SpO2 during the 5 minutes post-RSI
Time frame
5 minutes post-inductionSponsors and contacts
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Source ClinicalTrials.gov