Sedation
Conditions
Keywords
intravenous lidocaine coloscopy
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.
Interventions
DRUGplacebo
the control group will be given the same volume of saline.
DRUGlidocaine
the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fatigue score after colonoscopy | half a year | fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain socre after colonoscopy | half a year | pain were measured on a 0-10VAS at arrival in the recovery room ,30min later |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the rate of hypotention during the procedure | half a year | Hypotension, defined as systolic blood pressure \<90 mmHg |
| Safety assessed by the rate of breadycardia during the procedure | half a year | Bradycardia, defined as heart rate \<50 beats/min |
| Safety assessed by the rate of required airway management during the procedure | half a year | Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia |
| infusion pain when adminstrate propofol | half a year | infusion pain was divided into no pain, mide pain and severe pain |
| endoscopists satisfaction assessed by the performer | half a year | the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure |
| patient satisfaction assessed by the patient | half a year | the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure |
| anesthetist satisfaction assessed by the anesthestist | half a year | the anesthetist satisfacition score were assessed on a 0-10VAS after the procedure |
| Safety assessed by the rate of involuntary movement | half a year | Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement |
| Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure | half a year | Hypoxia, defined as peripheral oxygen saturation \<90% for \>10 seconds |
Countries
China
Contacts
Primary ContactJing Liu, MD
Backup Contactyanqing li, phD
Outcome results
None listed