An observational study in Rapide Sequence Induction, Tracheal Intubation and Nociception, sponsored by Centre Hospitalier Princesse Grace. Recruiting at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Centre Hospitalier Princesse Grace · Observational
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.
Background: RSI is a standard technique in anesthesia, primarily used to minimize the risk of aspiration. European guidelines leave the choice of hypnotic and neuromuscular blocking agent to the practitioner; the role of analgesics is not addressed. RSI induces sympathetic reactions linked to intense painful stimulation. Several monitors enable nociception assessment during general anesthesia, including in paralyzed patients (ANI, NOL, SPI). To date, no study has explored pain using the Analgesia Nociception Index during RSI.
Hypothesis: Rapid sequence induction induces sympathetic reactions associated with intense painful stimulation, which can be quantified using ANI.
Primary objective: To describe the impact on pain monitored by ANI of rapid sequence induction in anesthesia.
Secondary objectives: (1) Describe early complications (desaturation, hypotension, regurgitation); (2) Explore factors associated with pain; (3) Explore factors associated with complications.
Methods: Prospective monocentric observational cohort study, in routine care, with no additional examinations beyond standard management. Patients are monitored according to Société Française d'Anesthésie et de Réanimation (SFAR) guidelines, with additional non-invasive cutaneous electrodes placed on the right pectoral area for ANI monitoring. Induction begins after preoxygenation of at least 3 minutes. Induction drugs are at the discretion of the anesthesiologist. A timer is started at injection of the first induction drug (T0). Hemodynamic and ANI parameters are recorded during the first 5 minutes.
Data collected: date of intervention, age, sex, ASA score, Mallampati score, Cormack classification, preoperative analgesics (paracetamol within 4h, nefopam, tramadol, morphine, ketoprofen), induction drugs (hypnotic: propofol/etomidate/ketamine; opioid: remifentanil/alfentanil/sufentanil; neuromuscular blocker: succinylcholine/rocuronium), heart rate and systolic/diastolic blood pressure (T preO2, T1min, T3min, T5min), ANI and SpO2 (T preO2, minimum value \<5min), intubation device (McGrath / Airtraq / direct laryngoscopy), time between neuromuscular blocker injection and cuff inflation, presence of postoperative sore throat at 24h.
Statistical analysis: descriptive analysis of patient characteristics; mixed models for evaluation of variables over the 5 minutes post-RSI; multivariate models to identify associated risk factors. Two-sided p-values \<0.05 will be considered statistically significant. Analyses performed with R software.
Follow-up duration: 24 hours per patient. Total inclusion period: 24 months.
Centre Hospitalier Princesse Grace is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
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Patient requiring tracheal intubation after rapid sequence induction
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Exclusion Criteria:
Standard 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.
Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation
Time frame: 5 minutes post-induction
Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI
Time frame: 5 minutes post-induction
Occurrence of regurgitation during RSI
Time frame: 5 minutes post-induction
First-attempt intubation success rate
Time frame: At time of intubation
Variation of SpO2 during the 5 minutes post-RSI
Time frame: 5 minutes post-induction
Identification of factors associated with reduced pain (lower ANI variation)
Time frame: 5 minutes post-induction
Presence of sore throat 24 hours after intubation
Time frame: 24 hours post-intubation
Plan to share: No — Data are fully anonymized and collected in a routine care context; individual participant data will not be shared
Started May 2026 (actual). Primary completion is estimated for May 2028, 24 months after the start.
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Centre Hospitalier Princesse Grace