Effect of intravenous Lidocaine bolus on the median effective concentration (EC50) of Propofol during target controlled infusion (TCI : Schnider model) for gastroscopy in adult patients : a prospective, randomized, double-blinded study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hopital Erasme

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

8 Apr 2024 → 28 Jun 2024

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509888-24-00

ClinicalTrials.gov

NCT06143410

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

Primary = to evaluate the impact of an intravenous Lidocaine bolus (1.5 mg/kg ideal body weight) on the estimated
median effective concentration (EC50) of Propofol used during intravenous target concentration anesthesia
(AIVOC.: Schnider model) for gastroscopy.

Secondary objectives 1

1. Secondary = potential reduction in Propofol side effects (arterial hypotension / desaturation / apnea / bradycardia), lower incidence of pain on Propofol injection, lower incidence of coughing on gastroscope insertion, faster post-procedure recovery, lower incidence of throat pain, shorter time in post-anesthesia care unit, and at least equivalent patient satisfaction and gastroenterologist satisfaction with the endoscopic procedure.

Conditions and MedDRA coding

Gastroscopy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. All patients having to benefit from gastroscopy under narcosis at the ERASME hospital
2. Age between 18-65 years
3. ASA score I or II (American Society of Anesthesiologists)
4. Body mass index (BMI) between 18 and 30 kg/m2
5. Knowledge of French / French speakers
6. Signed written informed consent

Exclusion criteria 24

1. Any allergy or contraindication to one or more of the substances used
2. Severe liver failure
3. Cardiac arrhythmia (bradycardia < 50/min, atrioventricular block II-III, severe sino-atrial block)
4. Severe heart failure (LVEF < 30%)
5. Obesity (BMI > 30 kg/m2)
6. Proven sleep apnea syndrome or suspected sleep apnea syndrome with STOP-BANG score > 5
7. Have undergone local anesthesia within the previous 24 hours or general anesthesia within the previous 7 days
8. Methemoglobinemia
9. Porphyria
10. Pregnant or breast-feeding at the time of the study
11. History of intoxication by local anesthetics
12. Indication for oro-tracheal intubation
13. Emergency gastroscopy
14. Pre-gastroscopy premedication
15. Chronic consumption of powerful analgesics / drug addiction
16. Psychiatric disorder
17. Epilepsy
18. Severe renal failure (GFR < 30 ml/min/1.73m2)
19. History of malignant hyperthermia
20. Blood coagulation disorders
21. Anticoagulant medication
22. Upper lung infection
23. Mitochondrial disease
24. Drug interaction with Propofol and/or Lidocaine: concomitant use of Rifampicine, Valproate, Phenytoin, Cardiac glycosides (Digoxin), Class III antiarrhythmics (Amiodarone), Cimetidine, Barbiturates, Isoprenaline, Glucagon

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. estimated EC50 of propofol for gastroscope introduction without movements

Secondary endpoints 11

1. number of participants with moderate hypoxemia (pulse saturation below 95%) during propofol sedation and gastroscopy
2. number of participants with hypotension (mean arterial pressure below 65 mmHg) during propofol sedation and gastroscopy
3. number of participants presenting cough cough suggesting to light sedation during propofol sedation and gastroscopy
4. number of participants presenting laryngospasm laryngospasm suggesting to light sedation during propofol sedation and gastroscopy
5. number of participants presenting involuntary movements involuntary movements suggesting to light sedation during propofol sedation and gastroscopy
6. number of participants presenting side effects of lidocaine administration metallic taste, tinnitus, anaphylaxis
7. score of Endoscopist satisfaction (1-5) after completion of the procedure (Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent)
8. score of Patient satisfaction (1-5) at recovery room discharge, an average of 1 hour after completed procedure (Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent) ]
9. throat pain (analog digital scale from 1 to 10) at recovery room discharge, an average of 1 hour after completed procedure
10. Time to anesthesia recover : Time between stopping Propofol and recovering a MOAA/S score ≥ 4
11. Time for post anesthesic care unit discharge

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hopital Erasme

Sponsor organisation

Hopital Erasme

Address

Lennikse Baan 808

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

Hopital Erasme

Contact name

Pr Boudart Céline

Public contact point

Organisation

Hopital Erasme

Contact name

Pr Boudart Céline

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications