Comparison of mean arterial blood pressure and heart rate in both groups of patients undergoing percutaneous nephrolithotomy surgery (PCNL) with general anesthesia or spinal anesthesia.
Objectives: This study is aimed to compare the mean arterial pressure and heart rate in both groups of patients undergoing general anesthesia versus spinal anesthesia during percutaneous nephrolithotomy (PCNL) surgery. Design: Prospective randomized clinical trial. Setting and conduct : Tertiary regional and teaching hospital. Participants including major eligibility criteria: Sixty patients, with age 18-65yr; ASA Class I- II, undergoing PCNL in Shahid Hasheminejad Hospital during 2011-2012,were included . Patients were randomized into two groups of 30 each, using a table of random numbers. Intervention: control group , patients undergoing general anesthesia,Induced anesthesia with 3-5 mg/kg thiopental sodium and maintenance of anesthesia was achieved with propofol (100 mic/kg/min), and Study group , patients undergoing spinal anesthesia received 15-20 mg intrathecal bupivacaine isobar 0.5%. Main outcome measures (variables): Postoperative Visual analog scale (VAS); Blood pressure; Heart rate; Blood loss volume; Analgesic requirement, The need transfusion during recovery and ward. The technique of anesthesia are coded and delivered to the patients by and individual not aware of the research process. A stuff assessed Postoperative VAS; Blood pressure; Heart rate; Blood loss volume; Analgesic requirement, The need blood transfusion
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212228435N2
Registration date:2013-01-16, 1391/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-16, 1391/10/27
Registrant information
Name
Seyed Masoud Hashemi
Name of organization / entity
Department of Anesthesiology and Pain
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
mohammadinasab@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of mean arterial blood pressure and heart rate in both groups of patients undergoing percutaneous nephrolithotomy surgery (PCNL) with general anesthesia or spinal anesthesia.
Public title
Comparing the efficacy of general anesthesia and spinal anesthesia on blood pressure and heart rate changes in renal stone surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria of study: Age 18-65 yr;ASA Class I- II
Exclusion criteria of study: Contraindication for spinal anesthesia; Taking any pain medication 24 hours before surgery; Sensitivity to drug study; Substance abuse; Neurologic disease or neuromuscular or psychiatric disease; Chronic pain syndrome; Diabetes mellitus,hypertension,cardiovascular disease,coagulopathy disease; Injection of analgesic during spinal anesthesia; Pregnancy ; Sensory level above T4 or below T10
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Poursina Ave.
City
Tehran
Postal code
Approval date
2011-03-20, 1389/12/29
Ethics committee reference number
p/29-12-89
Health conditions studied
1
Description of health condition studied
Percutaneous nephrolithotomy
ICD-10 code
N20.0, N13
ICD-10 code description
First diagnosis of kidney stones
Primary outcomes
1
Description
Mean Arterial Blood Pressure
Timepoint
Intraoperative and Recovery
Method of measurement
mm Hg
2
Description
Heart Rate
Timepoint
Intraoperative and Recovery
Method of measurement
Number /min.
Secondary outcomes
1
Description
Consumption of Analgesic Amount
Timepoint
Recovery
Method of measurement
mg
2
Description
The need of blood transfusion
Timepoint
Intraoperative
Method of measurement
The volume of blood transfused in CC
3
Description
Intraoperative bleeding
Timepoint
Intraoperative
Method of measurement
Measured with the blood suctioned in cc by the graded container
Intervention groups
1
Description
In the study group, Spinal
anesthesia, 15-20 mg intrathecal bupivacaine isobar 0.5%
Category
Prevention
2
Description
In the control group, General anesthesia, Induced anesthesia with 3-5 mg/kg thiopental sodium and maintenance of anesthesia was achieved with propofol (100 mic/kg/min).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Valiallah Hassani
Street address
Valinejad Ave. above Vanak Squ. Valiasr St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh MD.
Street address
Poursina St.
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, Tehran University of Medical Sciences and Health Services
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
Rasul Hospital
Full name of responsible person
Valiallah Hassani
Position
Professor
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 216650905900
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Valiallah Hassani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 216650905900
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Valiallah Hassani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 216650905900
Fax
Email
vhassani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)