Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784860
• Other study ID #: LIDOCOLO2016JJCF
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2016
• Last updated: December 29, 2017
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• colonoscopy without gastroscopy

Exclusion Criteria:

• lidocaine allergy

• epilepsy

• severe heart rhythm disorders

• renal failure with creatinine clearance lower than 30ml/minute

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Lidocaine
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
• normal 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

Locations

Country	Name	City	State
Belgium	University Hospital of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of propofol	Dose of propofol administered during sedation if measured at the end of it.	intraoperative
Secondary	Episodes of oxygen desaturation	Episodes of oxygen desaturation: SpO2 < 95 and 90%	intraoperative
Secondary	Time for recovery	the patient is discharged when conscious and able to give his birth date	intraoperative
Secondary	Quality of working conditions assessed by the gastroenterologist		intraoperative
Secondary	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
Secondary	Postoperative fatigue	Fatigue will be assessed on a visual analog scale	15 min after sedation
Secondary	Cognitive condition	Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)	15 minutes after sedation