40 patients with end stage renal disease, age between 18 and 60 years and ASA class II-III will be enrolled in the study and randomly allocated into two treatment groups. In the first group (TCI), patients will receive remifentanil (4ng/ml) and propofol (4micg/ml) as effect site concentration target, respectively, during anesthesia and in the second group patients will receive sufentanil (10-15 mic bolus) and propofol (1.5 mg/kg) for induction and then N2O and Isoflurane(<1 MAC)for maintenance of anesthesia. Patients with any dependence to opioids and sedatives or with ASA more than III will be excluded from the study. Vital signs and BIS will be measured and compared in 7 different time points. Presence of nausea and vomiting, urine output and pain severity will be compared between two groups during 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710011361N2
Registration date:2009-01-05, 1387/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-01-05, 1387/10/16
Registrant information
Name
Naser Yeganeh
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
4276309 831 98+
Email address
nyeganeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pro-vice-chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2008-12-30, 1387/10/10
Expected recruitment end date
2009-05-30, 1388/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of target-controlled infusion anesthesia and balanced anesthesia in renal transplantation surgery
Public title
Comparison of two methods of anesthesia for renal transplantation surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 years, ASA class II-III, End Stage Renal Disease candidate for renal transplantation Exclusion criteria: ASA class more than III, denial of patients, any dependence to opioids or sedative agents.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Kermanshah University of Medical Sciences
Street address
Shahid-Beheshti Bulvard
City
Kermanshah
Postal code
Approval date
2008-01-29, 1386/11/09
Ethics committee reference number
420/4279
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End-stage Renal Disease
Primary outcomes
1
Description
Vital signs during renal transplantation surgery
Timepoint
T1: before induction of anesthesia, T2: immediately after intubation, T3: after skin incision, T4: before declamping renal artery, T5: after skin suture, T6: after extubation, T7: in the recovery room
Method of measurement
Clinical examination and non-invasive blood pressure measurement
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
every 2 h in first 24 h after operation
Method of measurement
observation,clinical examination
2
Description
Pain
Timepoint
Every 2 hour during 24 hours after operation
Method of measurement
visual analoge scale
3
Description
Urine output
Timepoint
Every 2 hour during 24 hours after operation
Method of measurement
Volume of urine output per hour
Intervention groups
1
Description
Remifentanil and Propofol with target controlled method
Category
empty
2
Description
IV induction with Sufentanil and Propofol and inhalational anesthesia with isoflurane and N2O for maintenance
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Naser Yeganeh - Mohamad Musavi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pro-vice-chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. H.Khazaie, Pro-vice chancellor for Research,
Street address
Shahid-Beheshti Bulvard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pro-vice-chancellor for Research, Kermanshah 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
Imam Reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza hospital, Departement of Anesthesia and Intensive Care
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/ Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)