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Impact of opioids on heart rate during rapid sequence intubation : Double-blind randomized controlled study (CANDY-CRASH).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501500-10-00
Enrollment
150
Registered
2022-11-21
Start date
2023-05-16
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

55-65 years old patients with ASA > 3 or patients over 65 years old with any ASA, requiring rapid sequence induction considered to have a full stomach during the anesthesia consultation (scheduled or urgent).

Brief summary

Absolute variation of heart rate beats per minute between T0 (reference value at the entrance into the operating room) and T2 (end of induction and oro-tracheal intubation).

Detailed description

1a- Cormack score in each group, 1b- Laryngoscopy of Macintosh® number for each group, 1c- Use of a long bent mandrel for each group, 2a- Percentage of patients with intraoperative vomiting at T2 for each group, 2b- Percentage of patients requiring vasopressor before T2, 2c- Percentage of patients with thoracic rigidity and/or bradycardia cardiac output < 50 beats per minute (bpm) at T2 for each group, 3a- Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2, 3b- Absolute and relative variations of +/- 20% in SAP/DAand MAP between T0 and T13, 3c- Relative variation of +/- 20% of HR between T0 and T2, 3d- Absolute and relative variations of +/- 20% of HR between T0 and T13.

Interventions

DRUGSODIUM CHLORIDE
DRUGSUFENTA 10 microgrammes/2 ml
DRUGsolution injectable (I.V. ou péridurale)
DRUGULTIVA 2 mg

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute variation of heart rate beats per minute between T0 (reference value at the entrance into the operating room) and T2 (end of induction and oro-tracheal intubation).

Secondary

MeasureTime frame
1a- Cormack score in each group, 1b- Laryngoscopy of Macintosh® number for each group, 1c- Use of a long bent mandrel for each group, 2a- Percentage of patients with intraoperative vomiting at T2 for each group, 2b- Percentage of patients requiring vasopressor before T2, 2c- Percentage of patients with thoracic rigidity and/or bradycardia cardiac output < 50 beats per minute (bpm) at T2 for each group, 3a- Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2, 3b- Absolute and relative variations of +/- 20% in SAP/DAand MAP between T0 and T13, 3c- Relative variation of +/- 20% of HR between T0 and T2, 3d- Absolute and relative variations of +/- 20% of HR between T0 and T13.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026