Overview
Sponsor-declared trial summary
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).
Assess the impact of opioids on heart rate due to laryngoscopy at the time of intubation in rapid sequence.
Key facts
- Sponsor
- Centre Hospitalier Sud Francilien
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 16 May 2023 → ongoing
- Decision date (initial)
- 2022-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501500-10-00
- ClinicalTrials.gov
- NCT05384665
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
Assess the impact of opioids on heart rate due to laryngoscopy at the time of intubation in rapid sequence.
Secondary objectives 3
- 1. improve intubation conditions
- 2. assess side effects according to the opioids used
- 3. assess significant variation in hemodynamic responses
Conditions and MedDRA coding
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).
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patient over 65 years old and any possible ASA OR Patient aged 55 to 65 years old with an ASA ≥ 3
- Patient undergoing surgery (urgent or scheduled), requiring general anesthesia in rapid sequence, because considered to have a "full stomach", i.e. with: gastro-oesophageal pathology or gastroparesis or a history of bariatric surgery or occlusive syndrome (with or without naso-gastric tube), or failure to respect food <6 hours and/or water <2 hours
- Patient regardless of body mass index (BMI)
- Patient regardless of their orotracheal intubation criteria present during the anesthesia consultation
- Patient informed of the study who gave their written consent before starting the study procedures
- Patient affiliated to a French social security system
Exclusion criteria 11
- Patient < 55 years old
- Patient on beta blockers
- Atrial fibrillation or other rhythm or conduction disturbances
- Patient in hemodynamic failure SBP < 90 mmHg and DBP < 60 mmHg) and/or on catecholamines before the start of GA
- Patient having a history of stroke, hemorrhagic and/or ischemic and/or transient
- Combination with opioid agonists-antagonists or partial opioid antagonists
- Known hypersensitivity to one of the study drugs or to opioids
- History of difficult intubation
- Patient under guardianship, curatorship or deprived of liberty
- Patient participating in another interventional clinical research
- Patient under AME (State Medical Aid)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 10
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
ULTIVA 2 mg, poudre pour solution injectable ou pour perfusion
PRD5214872 · Product
- Active substance
- Remifentanil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 0.5 µg/Kg microgram(s)/kilogram
- Max total dose
- 0.5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH06 — REMIFENTANIL
- Marketing authorisation
- 34009 560 140 2 6
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUFENTA 10 microgrammes/2 ml, solution injectable (I.V. ou péridurale)
PRD7253943 · Product
- Active substance
- Sufentanil Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 0.2 µg/Kg microgram(s)/kilogram
- Max total dose
- 0.2 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- 34009 561 146 4 1
- MA holder
- PIRAMAL CRITICAL CARE B.V.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 15 ml millilitre(s)
- Max total dose
- 15 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Sud Francilien
- Sponsor organisation
- Centre Hospitalier Sud Francilien
- Address
- 40 Avenue Serge Dassault
- City
- Corbeil Essonnes
- Postcode
- 91100
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Sud Francilien
- Contact name
- Dr Marine FONTAINE
Public contact point
- Organisation
- Centre Hospitalier Sud Francilien
- Contact name
- Caroline TOURTE
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-05-16 | 2023-05-16 | 2023-10-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary SUM-28391
|
2024-06-06T12:06:36 | Submitted | Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Summary of results (for publication) | CANDY-CRASH_resume-rapport-final_20240313_CTE-sgn | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-01 | France | Acceptable 2022-11-14
|
2022-11-21 |