Clinical trial NCT04439786: Intravenous Infusion of Lidocaine in Colonoscopy
Official title: Efficacy of Intravenous Infusion of Lidocaine in Sedation for Colonoscopy: a Randomised Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sedation
Keywords: intravenous lidocaine coloscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the patients satisfaction after sedation for colonoscopy.

Detailed description: This study divide patients into two groups, lidocaine group one will be given lidocaine intravenously; control group will be given saline . the difference between patients fatigue and pain will be compared. and the propofol consumption, pain after infusion of propofol, patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia, and bradycardia will aslo be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria: patients aged \>18 years who were scheduled for colonscopy at Qilu hospital.

Exclusion Criteria:patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 \<90%), hypotension (systolic blood pressure \<90 mm Hg), bradycardia (HR\<50 beats/min), uncontrolled hypertension (SBP \>170 mm Hg, diastolic blood pressure\>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen

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Primary outcomes:
measure: fatigue score after colonoscopy
timeFrame: half a year
Secondary outcomes:
measure: pain socre after colonoscopy
timeFrame: half a year
Other outcomes:
measure: infusion pain when adminstrate propofol
timeFrame: half a year
measure: Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of hypotention during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of breadycardia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of required airway management during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of involuntary movement
timeFrame: half a year
measure: endoscopists satisfaction assessed by the performer
timeFrame: half a year
measure: patient satisfaction assessed by the patient
timeFrame: half a year
measure: anesthetist satisfaction assessed by the anesthestist
timeFrame: half a year
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Shan dong China
role: STUDY_CHAIR
References: