Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

Study Overview
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Brief Summary
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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
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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

Official Title
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Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Lidocaine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: colonoscopy without gastroscopy Exclusion Criteria: lidocaine allergy epilepsy severe heart rhythm disorders renal failure with creatinine clearance lower than 30ml/minute

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h. | Drug: Lidocaine<br>* Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness<br>* Other names: XYLOCAINE ; (NDA) 006488;|
| Placebo Comparator: Placebo<br>Placebo Administration of normal saline: same volume of saline as lidocaine. | Drug: normal saline<br>* Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of propofol | Dose of propofol administered during sedation if measured at the end of it. | intraoperative | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, lidocaine, propofol, sedation