Use of Lidocaine in Endoscopic Submucosal Dissection

Gastric Neoplasm Clinical Trial

Official title:

Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543411
• Other study ID #: 4-2014-0933
• Status: Completed
• Phase: N/A
• First received: September 2, 2015
• Last updated: December 14, 2015
• Start date: September 2015

Study information

• Verified date: December 2015
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.

The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion Criteria:

1. Allergy to lidocaine

2. Chronic pain

3. Chronic abuse of opioid or NSAID

4. Atrioventricular conductance block

5. Liver dysfunction

6. Renal dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• Lidocaine 1%
Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation. Sedation with fentanyl and propofol
• Normal saline
Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation. Sedation with fentanyl and propofol

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl consumption during sedation		During sedation, an expected average of 40 minutes	Yes
Secondary	Pain intensity measured by numerical rating scale	0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale)	30 min, 6 hr, and 24 hr after procedure	No
Secondary	Incidence of nausea and vomiting	Nausea requiring antiemetics and retching and/or vomiting	Up to 24 hours	Yes