Pain Assessment During Rapid Sequence Induction

Официальное название

Nociception Assessment During Rapid Sequence Induction: A Prospective Observational Study of Practices and Complications - The NARSI Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No Intervention: Observational Cohort
  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.

Первичные конечные точки

• Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation [Срок оценки: 5 minutes post-induction]

Вторичные конечные точки (6)

• Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI [Срок оценки: 5 minutes post-induction]
• Occurrence of regurgitation during RSI [Срок оценки: 5 minutes post-induction]
• First-attempt intubation success rate [Срок оценки: At time of intubation]
• Variation of SpO2 during the 5 minutes post-RSI [Срок оценки: 5 minutes post-induction]
• Identification of factors associated with reduced pain (lower ANI variation) [Срок оценки: 5 minutes post-induction]
• Presence of sore throat 24 hours after intubation [Срок оценки: 24 hours post-intubation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patient with atrial fibrillation at the time of intubation following rapid sequence induction
• Patient on long-term beta-blocker therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Monaco · 1 центр

• Centre Hospitalier Princesse Grace — Monaco

Публикации

• Alanoglu Z, Tolu S, Yalcin S, Batislam Y, Ozatamer O, Tuzuner F. Different remifentanil doses in rapid sequence anesthesia induction: BIS monitoring and intubation conditions. Adv Clin Exp Med. 2013 Jan-Feb;22(1):47-55. PMID 23468262
• O'Hare R, McAtamney D, Mirakhur RK, Hughes D, Carabine U. Bolus dose remifentanil for control of haemodynamic response to tracheal intubation during rapid sequence induction of anaesthesia. Br J Anaesth. 1999 Feb;82(2):283-5. doi: 10.1093/bja/82.2.283. PMID 10365011
• 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. PMID 31614244
• Voeltzel J, Garnier O, Prades A, Carr J, De Jong A, Molinari N, Jaber S, Chanques G. Assessing pain in paralyzed critically ill patients receiving neuromuscular blocking agents: A monocenter prospective cohort. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101384. doi: 10.1016/j.accpm.2024.101384. Epub 2024 May 6. PMID 38710326
• Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17. PMID 25032676
• Funcke S, Sauerlaender S, Pinnschmidt HO, Saugel B, Bremer K, Reuter DA, Nitzschke R. Validation of Innovative Techniques for Monitoring Nociception during General Anesthesia: A Clinical Study Using Tetanic and Intracutaneous Electrical Stimulation. Anesthesiology. 2017 Aug;127(2):272-283. doi: 10.1097/ALN.0000000000001670. PMID 28489614
• Grillot N, Gonzalez V, Deransy R, Rouhani A, Cintrat G, Rooze P, Naux E, Volteau C, Bouras M, Cinotti R, Roquilly A. Post-induction hypotension during rapid sequence intubation in the operating room: A post hoc analysis of the randomized controlled REMICRUSH trial. Anaesth Crit Care Pain Med. 2025 May;44(3):101502. doi: 10.1016/j.accpm.2025.101502. Epub 2025 Mar 12. PMID 40086728
• Grillot N, Lebuffe G, Huet O, Lasocki S, Pichon X, Oudot M, Bruneau N, David JS, Bouzat P, Jobert A, Tching-Sin M, Feuillet F, Cinotti R, Asehnoune K, Roquilly A; Atlanrea Study GroupSociete Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients PMID 36594947

Идентификаторы

NCT: NCT07588165 · 26-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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