Impact of Opioids on Heart Rate During Rapid Sequence Intubation

Rapid Sequence Induction Clinical Trial

— CANDY-CRASH  

Official title:

Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05384665
• Other study ID #: EUCT 2022-500369-28-00
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: October 18, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.

Patients will be divided into 3 parallel groups :

• Group A (placebo +remifentanil)

• Group B (sufentanil + placebo)

• Group C (placebo + placebo)

Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.

To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.

The MAR injects the drugs according to the standardized study plan (see below):

• T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1

• 3 minute delay

• Patient receives Etomidate 0.3 mg/kg IV over 10 seconds

• 5 second delay

• The patient receives an IV bolus over 30 seconds of molecule n°2

• 5 second delay

• The patient receives Succinylcholine or Rocuronium IV over 5 seconds

• T2: End of induction, oro-tracheal intubation (= T2)

The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).

Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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 food intake within two hours for liquids and within six hours for solids,

• 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:

• Patient < 55 years old,

• Patient on beta blockers,

• Atrial fibrillation or other rhythm or conduction disturbances,

• Patient in hemodynamic failure 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)

Related Conditions & MeSH terms

• Rapid Sequence Induction

Intervention

Drug:
• Remifentanil
REMIFENTANIL, 5 µg/cc, solution for injection, 0.5 µg/kg, parenteral (intravenous) route, injection delay of 30 seconds, once only
• Sufentanil
SUFENTANIL, 5 µg/cc, solution for injection, 0.2 µg/kg, parenteral (intravenous) route, bolus over 5 seconds, once
• Placebo
PLACEBO contains 0.9% NaCl, parenteral (intravenous), bolus, one-time

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate beats per minute	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)	T2 : oro-tracheal induction
Secondary	Cormack score	Cormack score in each group	T2 : oro-tracheal induction
Secondary	Laryngoscopy of Macintosh number	Laryngoscopy number for each group	T2 : oro-tracheal induction
Secondary	Use of a long bent mandrel	Use of a long bent mandrel for each group	T2 : oro-tracheal induction
Secondary	assess side effects according to the opioids used	Percentage of patients with intraoperative vomiting at T2 for each group	T2 : oro-tracheal induction
Secondary	assess side effects according to the opioids used	Percentage of patients requiring vasopressor before T2	before T2 : oro-tracheal induction
Secondary	assess side effects according to the opioids used	Percentage of patients with thoracic rigidity and/or bradycardia < 50/min at T2 for each group	T2 : oro-tracheal induction
Secondary	assess significant variation in hemodynamic responses	Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2	T2 : oro-tracheal induction
Secondary	assess significant variation in hemodynamic responses	Absolute and relative variations of +/- 20% in SAP/DA and MAP between T0 and T13	T13 (10 minutes after intubation)
Secondary	assess significant variation in hemodynamic responses	Relative variation of +/- 20% of HR between T0 and T2	T2 : oro-tracheal induction
Secondary	assess significant variation in hemodynamic responses	Absolute and relative variations of +/- 20% of HR between T0 and T13.	T13 (10 minutes after intubation)