80 patients aged between 65-5 years candidates for trans urethral prostatectomy with ASA class I and II would e allocated one of two study groups. One group will take 7.5 mg bupivacaine 0.5% and 25 µgr fentanyl while another group would tale only 10 mg of bupivacaine 0.5%. Blood Pressure, pulse rate and O2 saturation would be monitored during surgery. Then spinal anesthesia with 25 gauge needle in lumbar L3-L4 or L4-L5 would be done. Then anesthesia leveling would be taken during 5th, 10th and 30th minutes using a sterile needle. The time of anesthesia by adding the time of sensory recovery to two levels lower than the most upper primary level would be documented. Motor block also would be documented at 10th, 20th and 30th minutes using Bromidge score. If the patient complains pain during operation (VAS=4-6) 25 µgr fentanyl and if VAS>7 general anesthesia would be induced. Systolic Blood pressure, pulse rate would be documented before and after anesthesia induction during surgery. SBP<90 mmhg would be managed with ephedrine, while if decreased blood pressure is accompanying with heart rate lower than 60 beats, atropine would be administered. Itching, nausea, vomiting and respiratory depression during and after operation would be documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702226148N4
Registration date:2017-06-02, 1396/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Hakimeh Alreza Amiri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
halereza@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol research deputy of university of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose bupivacaine and fentanyl in spinal anesthesia on the level of sensory and motor block in elderly patients
Public title
The effect of bupivacaine and fentanyl level of sensory and motor in elderly patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age 65 to 85 candidates for prostatectomy
Exclusion criteria: patients with a history of bleeding disorders, neurological diseases, loss of consciousness, presence of infection at the injection site
Age
From 65 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Babol University of Medical Science
Street address
Rohani Hospital, Ganjafrooz Street
City
Babol
Postal code
4717641367
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
MUBABOL.REC.1394.178
Health conditions studied
1
Description of health condition studied
Sensory-Motor Block
ICD-10 code
R00–R99
ICD-10 code description
Symptoms and signs involving the nervous and musculoskeletal systems
Primary outcomes
1
Description
Level of sensory block
Timepoint
Minutes:10 ,20 after spinal anesthesia
Method of measurement
Sensory level was assessed using the tip of a needle sterilized and with alcohol cotton.
Secondary outcomes
1
Description
Motor block
Timepoint
Minutes: 10,20,30 and in the end of surgery and 2hours after spinal anesthesia
Method of measurement
Motor block was assessed and recorded using Bromage Scale( BS=0 full knee and foot flexion, BS=1 ability to move knee, BS=2 ability to move feet only, BS=3 full motor block)
2
Description
Patient s blood pressure
Timepoint
Blood pressure was monitored and recorded every 3 minutes for the first 10 minutes following spinal anesthesia and then every 5 minutes until completion of surgery.
Method of measurement
Noninvasive blood pressure cuff
3
Description
Patient s heart rate
Timepoint
Heart rate was monitored and recorded every 3 minutes for the first 10 minutes following spinal anesthesia and then every 5 minutes until completion of surgery.
Method of measurement
Monitoring of ECG and Pulse oximetry
4
Description
Pain
Timepoint
Minutes: 10,20,30 during surgery.
Method of measurement
VAS (Visual Analogues Scale)
5
Description
Nausea and vomiting
Timepoint
During surgery.
Method of measurement
Question & observation
6
Description
Respiratory depression
Timepoint
After spinal anesthesia
Method of measurement
Examination& observation
Intervention groups
1
Description
In intervention group, standard regimen including bupivacaine 0.5 % (7.5 gr Astra Zeneca, Sweden) and Fentanyl (25 µgr, Rotexmedic, Germany) was prescribed.
Category
Treatment - Drugs
2
Description
In control group, standard regimen including bupivacaine 0.5 % (7.5 gr Astra Zeneca, Sweden)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Hakimeh Alereza Amiri
Street address
Ganjafrooz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Babol Univercity of Medical Science
Full name of responsible person
Dr Ali Bigani
Street address
Babol Univercity of Medical Science, Ganjafrooz Street
City
Babol
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, Babol Univercity of Medical Science
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
Babol University of Medical Scince
Full name of responsible person
Dr Maedeh Jafarzadeh
Position
Residents of Anesthesiology
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
dr.jafarzadeh2011@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza
Position
Anesthesiologist
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
halereza@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Hakimeh Alereza
Position
Anesthesiologist
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)