Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Lidocaine; Drug: normal saline

• Registration Number: NCT02784860
• Lead Sponsor: University of Liege

Brief Summary

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)

Detailed 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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• colonoscopy without gastroscopy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.
Placebo	normal saline	Placebo Administration of normal saline: same volume of saline as lidocaine.

Primary Outcome Measures

Name	Time	Method
Consumption of propofol	intraoperative	Dose of propofol administered during sedation if measured at the end of it.

Secondary Outcome Measures

Name	Time	Method
Episodes of oxygen desaturation	intraoperative	Episodes of oxygen desaturation: SpO2 \< 95 and 90%
Time for recovery	intraoperative	the patient is discharged when conscious and able to give his birth date
Quality of working conditions assessed by the gastroenterologist	intraoperative
Abdominal discomfort	intraoperative and 15 minutes later	Evaluation with VAS (visual analog scale) form 0 (no discomfort) to 10 (unbearable Abdominal discomfort assessed on a 0 to 10 visual analog scale
Postoperative fatigue	15 min after sedation	Fatigue will be assessed on a visual analog scale
Cognitive condition	15 minutes after sedation	Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)

Trial Locations

Locations (1)

University Hospital of Liege; 🇧🇪 Liege, Belgium