Rapide Sequence InductionNARSINCT07588165
Pain Assessment During Rapid Sequence Induction
An observational study of Rapide Sequence Induction and Tracheal Intubation, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapide Sequence Induction, Tracheal Intubation, Nociception
- How many people
- 150 participants
- Where
- 1 siteMonaco
- Study dates
- 21 May 2026to May 2028
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient requiring tracheal intubation after rapid sequence induction
Who may be able to join
- 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
Who cannot join
- Patient with atrial fibrillation at the time of intubation following rapid sequence induction
- Patient on long-term beta-blocker therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Rémy WIDEHEM, MD, 0037797989900, remy.widehem@chpg.mc
About this study
Official title: Nociception Assessment During Rapid Sequence Induction: A Prospective Observational Study of Practices and Complications - The NARSI Study
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.
Read the detailed description
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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Analgesia Nociception Index (ANI), Rapid Sequence Induction (RSI), Pain monitoring, Tracheal intubation, Hemodynamic response, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation
Measured: 5 minutes post-induction
Secondary outcomes (6)
Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI
Measured: 5 minutes post-induction
Occurrence of regurgitation during RSI
Measured: 5 minutes post-induction
First-attempt intubation success rate
Measured: At time of intubation
Variation of SpO2 during the 5 minutes post-RSI
Measured: 5 minutes post-induction
Identification of factors associated with reduced pain (lower ANI variation)
Measured: 5 minutes post-induction
Presence of sore throat 24 hours after intubation
Measured: 24 hours post-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start21 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rapide Sequence InductionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Remy WIDEHEM, MD, Principal investigator, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588165
- Sponsor's protocol ID
- 26-03
- Acronym
- NARSI
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are fully anonymized and collected in a routine care context; individual participant data will not be shared
Publications
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.
PubMed 23468262O'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.
PubMed 10365011Chaumeron 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 31614244Voeltzel 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.
PubMed 38710326Gruenewald 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.
PubMed 25032676Funcke 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.
PubMed 28489614Grillot 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.
PubMed 40086728Grillot 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 at Risk of Aspiration: A Randomized Clinical Trial. JAMA. 2023 Jan 3;329(1):28-38. doi: 10.1001/jama.2022.23550.
PubMed 36594947Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24.
PubMed 26917599Greer A, Hewitt M, Khazaneh PT, Ergan B, Burry L, Semler MW, Rochwerg B, Sharif S. Ketamine Versus Etomidate for Rapid Sequence Intubation: A Systematic Review and Meta-Analysis of Randomized Trials. Crit Care Med. 2025 Feb 1;53(2):e374-e383. doi: 10.1097/CCM.0000000000006515. Epub 2024 Nov 21.
PubMed 39570063Acquisto NM, Mosier JM, Bittner EA, Patanwala AE, Hirsch KG, Hargwood P, Oropello JM, Bodkin RP, Groth CM, Kaucher KA, Slampak-Cindric AA, Manno EM, Mayer SA, Peterson LN, Fulmer J, Galton C, Bleck TP, Chase K, Heffner AC, Gunnerson KJ, Boling B, Murray MJ. Society of Critical Care Medicine Clinical Practice Guidelines for Rapid Sequence Intubation in the Critically Ill Adult Patient. Crit Care Med. 2023 Oct 1;51(10):1411-1430. doi: 10.1097/CCM.0000000000006000. Epub 2023 Sep 14.
PubMed 37707379