Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

• Sponsor: Erasme University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05944887
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation during gastroscopy in healthy patients (ASA 1 and 2 patients).

Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.

After the gastroscopy, patients will be asked to complete a satisfaction questionnaire

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Gastroscopy	Drug: Lidocaine 2% Injectable Solution; Drug: Saline administration as placebo; Drug: Propofol injection; Procedure: gastroscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
• Primary Purpose: Supportive Care
• Official Title: Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Linisol Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction	Drug: Lidocaine 2% Injectable Solution; administration of a bolus of lidocaine 1.5 mg/kg; Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol; Procedure: gastroscopy; esogastroduodenoscopy
Placebo Comparator: Sham Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction	Drug: Saline administration as placebo; administration of a bolus of saline solution as a placebo; Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol; Procedure: gastroscopy; esogastroduodenoscopy

Outcome Measures

Primary Outcome Measures

1. total propofol dose in milligramme [procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)]

   total propofol dose consumed

2. total propofol dose in milligramme [Procedure (from the beginning of propofol infusion until endoscope removal)]

   total propofol dose consumed

3. propofol in site effet concentration in microgram per milliliter [procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)]

   AIVOC : Effect concentration of propofol

4. propofol in site effet concentration in microgram per milliliter [Procedure (from the beginning of propofol infusion until endoscope removal)]

   AIVOC : Effect concentration of propofol

Secondary Outcome Measures

1. number of participants with moderate hypoxemia [Procedure (during propofol sedation and gastroscopy)]

   pulse saturation below 95%

2. number of participants with hypotension [Procedure (during propofol sedation and gastroscopy)]

   mean arterial pressure below 65 mmHg

3. number of participants with severe hypoxemia [Procedure (during propofol sedation and gastroscopy)]

   pulse saturation below 90%

4. number of participants presenting cough [Procedure (during propofol sedation and gastroscopy)]

   cough suggesting to light sedation

5. number of participants presenting laryngospasm [Procedure (during propofol sedation and gastroscopy)]

   laryngospasm suggesting to light sedation

6. number of participants presenting involuntary movements [Procedure (during propofol sedation and gastroscopy)]

   involuntary movements suggesting to light sedation

7. number of participants presenting side effects of lidocaine administration [during gastroscopy procedure]

   metallic taste, tinnitus, anaphylaxis

8. score of Endoscopist satisfaction (1-5) [completed procedure (before transfer to recovery room)]

   Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent

9. 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

10. throat pain [at recovery room discharge, an average of 1 hour after completed procedure]

    analog digital scale from 1 to 10

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for gastroscopy under narcosis and who have signed the consent.

• ASA score: 1 and 2

• BMI between 18 and 30 kg/m2

Exclusion Criteria:

• Lidocaine allergy

• Anesthesia within the last 7 days

• Use of local anesthesia in the last 24 hours

• Rhythm disorder or HR <50

• Pregnant women and breastfeeding

• Participation in another clinical study in the last months

• Cannot understand VAS score or French

• Severe central nervous disease and mental illness.

• obstructive sleep apnea (known or STOP BANG score >5)

• Upper lung infection.

• Liver or kidney function disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme Hospital	Brussel		Belgium	1070

Sponsors and Collaborators

• Erasme University Hospital

Investigators

• Principal Investigator: celine Boudart, MD PhD, Erasme University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hu S, Wang M, Li S, Zhou W, Zhang Y, Shi H, Ye P, Sun J, Liu F, Zhang W, Zheng L, Hou Q, Wang Y, Sun W, Chen Y, Lu Z, Ji Z, Liao L, Lv X, Wang Y, Wang X, Yang H. Intravenous Lidocaine Significantly Reduces the Propofol Dose in Elderly Patients Undergoing Gastroscopy: A Randomized Controlled Trial. Drug Des Devel Ther. 2022 Aug 12;16:2695-2705. doi: 10.2147/DDDT.S377237. eCollection 2022.
• Qi XR, Sun JY, An LX, Zhang K, Xue FS. Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial. Trials. 2022 Sep 24;23(1):800. doi: 10.1186/s13063-022-06719-6.
• Qi XR, Sun JY, An LX, Zhang K. Effect of intravenous lidocaine on the ED50 of propofol for inserting gastroscope without body movement in adult patients: a randomized, controlled study. BMC Anesthesiol. 2022 Oct 17;22(1):319. doi: 10.1186/s12871-022-01861-9.

• Responsible Party: Omar Assam, principal investigator, Erasme University Hospital
• ClinicalTrials.gov Identifier: NCT05944887
• Other Study ID Numbers: P2023/236
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lidocaine; Propofol

Study Results

No Results Posted as of Jul 13, 2023