Objectives Effect of acid-base balance on neuromuscular blockage in renal transplant, estimation the time of reversal of muscular blockage 3from 4 after de clump, evaluation of acidosis during the surgery and after de clump. Design study will be double blind clinical trial that each of two group contain of 15 number of patients in age between 18 to 70 who have end stage renal disease and candidate for alive donors kidney transplantation. Setting and conduct first will accumulate the demographics and clinical information of patient such as age, sex, weight, and time after last hemodialysis, time from beginning end stage renal disease and ABG (Arterial Blood Gas) basis and ABG in de clump and registration TOF(Train of forth) due to estimation of muscular relaxation from induction until the end of surgery in form. Inclusion criteria: Patient with ESRD(End stage Renal Disease) candidate for renal transplantation from live donor; patient aged between 18-70; patient satisfied to cooperate in proposal.
Exclusion criteria: patient with sever heart disease; Metabolic acidosis PH<7.15; duration of operation>3 hours; Body temperature in axillary < 35 degree Centigrade or >38.5 degree centigrade; Requirement for transfusion; aged <18 or >70 year; unsatisfaction of patient. Intervention will be administration of bicarbonate and correction the acidosis. Main outcome measures (variables) will be time of reversal muscular blockage, acidosis, bicarbonate, Carbone dioxide on base of arterial blood gas.
Vice Chancellor for research of Anesthesiology Center Shahid Beheshti University.
Expected recruitment start date
2015-10-21, 1394/07/29
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acid-base balance on neuromuscular blockage in renal transplant
Public title
Effect of acid-base balance on neuromuscular blockage in renal transplant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patient with ESRD(End stage Renal Disease) candidate for renal transplantation from live donor;patient aged between 18-70; patient satisfied to cooperate in proposal.
Exclusion criteria:patient with sever heart disease; Metabolic acidosis PH<7.15; duration of operation>3 hours; Body temperature in axillary < 35 degree Centigrade or >38.5 degree centigrade; Requirement for transfusion ; aged <18 or >70 year;unsatisfaction of patient .
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Shahiid Beheshtie University of Medical Sciences
Street address
Kodakyar Street,Arabi Avenue, Velenjac
City
Tehran
Postal code
Approval date
2015-12-26, 1394/10/05
Ethics committee reference number
IR.SBMU.REC.1394.105
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N17,N18,N1
ICD-10 code description
Renal Failure
Primary outcomes
1
Description
Time of revesal neuromuscular loose
Timepoint
Time between inject muscle relaxant and reversal
Method of measurement
measure with TOFSCAN
Secondary outcomes
1
Description
PH
Timepoint
During surgery
Method of measurement
Arterial Blood Gas
2
Description
HCO3
Timepoint
During surgery
Method of measurement
Arterial Blood Gas
3
Description
CO2
Timepoint
During surgery
Method of measurement
Arterial Blood Gas
4
Description
Base excess
Timepoint
During surgery
Method of measurement
Arterial Blood Gas
5
Description
Duration of Renal Failure
Timepoint
From the time started dialysis
Method of measurement
Measuring years
Intervention groups
1
Description
Intervention Group receive sodium bicarbonate upon the Base Excess
Category
Treatment - Drugs
2
Description
Control Group receive saline equal volume of intervention group