Colonoscopy
Conditions
Keywords
colonoscopy, lidocaine, propofol, sedation
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
Interventions
DRUGLidocaine
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
DRUGnormal saline
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
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* colonoscopy without gastroscopy
Exclusion criteria
* lidocaine allergy * epilepsy * severe heart rhythm disorders * renal failure with creatinine clearance lower than 30ml/minute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of propofol | intraoperative | Dose of propofol administered during sedation if measured at the end of it. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Episodes of oxygen desaturation | intraoperative | Episodes of oxygen desaturation: SpO2 \< 95 and 90% |
| 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) |
| 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 |
Countries
Belgium
Outcome results
None listed