Objective: To assess the effect of intravenous infusion of lidocaine in the comfort of the patient in the recovery room after surgery, PCNL Design: Randomized, double-blind, single-center, phase II clinical trial. Performance: Group of intravenous lidocaine infusion to the patient mg / kg / h 1.5 until the end of the operation received an IV infusion. The control group received lidocaine infusion. Inclusion criteria included: patients ASA1 (without any medical conditions or mental), age between 20 years to 60 years. Exclusion criteria included: age less than 20 years and more than 60 years, ASAII and higher sensitivity to lidocaine, kidney surgery, drug addiction, dependence on various drugs. Interventions: The first group of mg / kg / h 1.5 until the end of the operation received an IV infusion, the second group received lidocaine infusion. The main outcome variables: quality of sedation is intravenous infusion of lidocaine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011732017N1
Registration date:2017-03-24, 1396/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-24, 1396/01/04
Registrant information
Name
Mahmoud Reza Mohaghegh Dolat Abadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 140 6348
Email address
mohaghegh.mr@moheb.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intravenous infusion of lidocaine on the sedation of patient after percutaneous nephrolithotomy surgery
Public title
Effects of intravenous infusion of lidocaine in the sedation of patient in recovery after percutaneous nephrolithotomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Patients under percutaneous nephrolithotomy surgery. Exclusion criteria included: Age less than 20 years and more than 60 years; ASAII and higher; sensitivity to lidocaine and kidney surgery.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2015-07-04, 1394/04/13
Ethics committee reference number
IR.IUMS.rec.1394.921117418
Health conditions studied
1
Description of health condition studied
Urinary stone
ICD-10 code
N21.0
ICD-10 code description
Urinary bladder stone
Primary outcomes
1
Description
Quality of sedation
Timepoint
After treatment
Method of measurement
Based on Richmond Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients received an lidocaine IV infusion 1.5 mg/kg /h until the end of the operation.
Category
Treatment - Drugs
2
Description
Control group: Patients not received an lidocaine IV infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
Dr. Mahmudreza Mohaghegh
Street address
Vali nezhad Ave, Hashemi Nejad Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahmudreza Mohaghegh
Position
Ph.D., Assistant Professor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 912 298 9628
Fax
Email
Mohaghegh.mr@moheb.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahmudreza Mohaghegh
Position
PhD
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 912 298 9628
Fax
Email
Mohaghegh.mr@moheb.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahmudreza Mohaghegh
Position
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
00
Fax
Email
Mohaghegh.mr@moheb.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)