Centre Hospitalier Princesse Grace
Monaco, 98000
Location status: Recruiting
NCT Number: NCT07588165
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Monaco, 98000
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 5 minutes post-induction
Time frame: 5 minutes post-induction
Time frame: 5 minutes post-induction
Time frame: At time of intubation
Time frame: 5 minutes post-induction
Time frame: 5 minutes post-induction
Time frame: 24 hours post-intubation
Contact information is provided by the study sponsor or research team.
Celine DUGOURD
CONTACT
Remy WIDEHEM
CONTACT
Centre Hospitalier Princesse Grace
Other
Nociception Assessment During Rapid Sequence Induction: A Prospective Observational Study of Practices and Complications - The NARSI Study
Acronym: NARSI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07699653
Airway Management, General Anesthesia
Guangzhou, Guangdong, China
View Trial DetailsNCT07495436
Difficult Airway Intubation, General Anesthesia
Santiago de Compostela, A CORUÑA, Spain
View Trial DetailsNCT07716891
Elective Surgery, General Anesthesia
Yinchuan, China
View Trial DetailsNCT06982209
General Anesthesia, Laparoscopic Cholecystectomy
Iksan, Jeollabuk-do, South Korea
View Trial Details