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NCT Number: NCT07588165

Pain Assessment During Rapid Sequence Induction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

No Intervention: Observational Cohort

Other

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.

Primary outcomes

  1. Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation

    Time frame: 5 minutes post-induction

Secondary outcomes

  1. Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI

    Time frame: 5 minutes post-induction

  2. Occurrence of regurgitation during RSI

    Time frame: 5 minutes post-induction

  3. First-attempt intubation success rate

    Time frame: At time of intubation

  4. Variation of SpO2 during the 5 minutes post-RSI

    Time frame: 5 minutes post-induction

  5. Identification of factors associated with reduced pain (lower ANI variation)

    Time frame: 5 minutes post-induction

  6. Presence of sore throat 24 hours after intubation

    Time frame: 24 hours post-intubation

Study contacts

Contact information is provided by the study sponsor or research team.

Celine DUGOURD

CONTACT

[email protected]

+377 97 98 84 29

Remy WIDEHEM

CONTACT

[email protected]

+377 97 98 99 00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Registry information

Official study title

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

Acronym: NARSI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
May 27, 2026

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.

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