Comparison of hemodynamic changes and patients satisfaction(analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle
This study is a single blind, randomized clinical trial. The purpose of this study is comparison of hemodynamic changes and patients satisfaction (analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle. Inclusion criteria: the patient's complete satisfaction; ASA class I & II and age between 20-50 years old. Exclusion criteria: contraindications of Saddle Anesthesia (patient refusal; infection at the site of planned needle puncture; elevated intracranial pressure); allergy or contraindication to any of the drugs used in the study; severe cardiovascular, respiratory, metabolic, or neurologic diseases. 120 Patients will be allocated into two groups according to table of random numbers. Group "one" 5-10 minutes before biopsy will receive one dose 1 mcg /kg Intravenous Fentanyl and one dose 0.05 mg/kg Intravenous Midazolam for sedation. In group "two" Saddle anesthesia with one dose 12 mg of hyperbaric bupivacaine will perform for patients in the sitting position at L3-L4 interspace using a 25-gauge Whitacre needle. After drug injection, the patients must be stay in the sitting position at least 3-5 minutes and then the patients will turn to supine position. Hemodynamic changes and patients’ satisfaction with VAS (Visual Analogue Scale) at end of biopsy, 10, and 20 minutes after surgery will measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102315136N1
Registration date:2013-11-08, 1392/08/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-08, 1392/08/17
Registrant information
Name
mohamad sahraeian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
sahraeian.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes and patients satisfaction(analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle
Public title
Comparison of hemodynamic changes and patients satisfaction(analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patient's complete satisfaction; -ASA class I & II and age between 20-50 years old .
Exclusion criteria: contraindications of Saddle Anesthesia( patient refusal; infection at the site of planned needle puncture; elevated intracranial pressure); allergy or contraindication to any of the drugs used in the study; severe cardiovascular, respiratory, metabolic, or neurologic diseases.
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Approval date
2012-10-12, 1391/07/21
Ethics committee reference number
Eth-636
Health conditions studied
1
Description of health condition studied
Pain during Prostate biopsy
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Hemodynamic Changes
Timepoint
End of Biopsy, 10, and 20 minutes after surgery
Method of measurement
Blood Pressure Measurement
Secondary outcomes
1
Description
Patient Satisfaction of Pain Control
Timepoint
End of Biopsy, 10, and 20 minutes after surgery
Method of measurement
Visual Analoge Scale
Intervention groups
1
Description
Group "one" 5-10 minutes before biopsy will receive one dose 1 mcg /kg Intravenous Fentanyl and one dose 0.05 mg/kg Intravenous Midazolam for Sedation.
Category
Treatment - Drugs
2
Description
Group "two" Saddle anesthesia with one dose 12 mg of hyperbaric bupivacaine will perform for patients in the sitting position at L3-L4 interspace using a 25-gauge Whitacre needle.