Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

University of Liege

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: normal saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02784860

LIDOCOLO2016JJCF

Details and patient eligibility

About

This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.

Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)

Full description

The potential benefits of lidocaine infusion will be tested on:

• propofol consumption (primary outcome)
• intraoperative respiratory depression
• time for patient recovery
• postoperative fatigue
• postoperative pain
• postoperative cognitive dysfunction

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• colonoscopy without gastroscopy

Exclusion criteria

• lidocaine allergy
• epilepsy
• severe heart rhythm disorders
• renal failure with creatinine clearance lower than 30ml/minute

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Placebo Administration of normal saline: same volume of saline as lidocaine.

Treatment:

Drug: normal saline