Objective:
The addition of opioids to local anesthetics in spinal anesthesia modulates some aspects of anesthesia and analgesia. In this study, the effect of adding intrathecal fentanyl on bispectral index (BIS) during spinal anesthesia will be evaluated.
Materials and Methods:
According to prospective clinical trial studies, the patients undergoing lower limb orthopedic surgery will randomly be divided into 2 groups of control and intervention ones. Inclusion criteria will be physical status class I from the perspective of American Society of Anesthesiologists; planned for lower limb orthopedic surgery undergoing spinal anesthesia; and lack of opioid addiction. Exclusion criteria will be spinal anesthesia contraindications; any unusual complications including a lot of bleeding during surgery; and prolonged surgery. The control group will receive 12.5 mg of 0.5% hyperbaric bupivacaine (Astrazeneca) (HBB), while the intervention group will receive 12.5 mg of HBB plus 20 µg of intrathecal fentanyl (Abureyhan). After the induction of spinal anesthesia, a bispectral index (BIS) monitor will be connected and baseline values will be recorded for each patient. BIS, vital signs, nausea and vomiting and shivering will also be recorded for each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080627677N4
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Urmia University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrathecal fentanyl on bispectral index during spinal anesthesia in patients with lower limb orthopedic surgery.
Public title
Clinical trial the effect of intrathecal opioid on bispectral index in patient with lower limb orthopedic surgery under spinal anesthesia.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
physical status class I from the perspective of America society of Anesthesiologists; lower limb orthopedic surgery with spinal anesthesia; Lack of opioid addiction
Exclusion criteria:
spinal anesthesia contraindications; any unusual complications including a lot of bleeding during surgery; prolonged surgery
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be divided into two groups by random number table .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Emergent Street, Resalat Avenue, Urmia
City
Urmia
Postal code
5714783734
Approval date
2015-08-06, 1394/05/15
Ethics committee reference number
ir.umsu.rec.1394.273
Health conditions studied
1
Description of health condition studied
sedation in spinal anesthesia
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament
Primary outcomes
1
Description
level of consciousness
Timepoint
Bispectral index will be recorded at baseline and 5, 10, 15, 30, 45 and 60 minutes after spinal injection.
Method of measurement
Bispectral Index Monitoring
Secondary outcomes
1
Description
Mean Arterial Blood Pressure
Timepoint
Mean Arterial Pressure will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline.
Method of measurement
None Invasive Blood Pressure
2
Description
Heart Rate
Timepoint
Heart Rate will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline.
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Intervention group: will receive hyperbaric bupivacaine with intrathecal fentanyl. In sitting position lumbar puncture will done using a 25 gauge needle (Exel) into the subarachnoid space L3-L4 in the midline just cephalad. After cerebrospinal fluid aspiration, 2.5 ml of 0.5% hyperbaric bupivacaine (Astrazeneca) plus 20 µg fentanyl (Abureyhan) will inject.
Category
Diagnosis
2
Description
Control group: will receive alone hyperbaric bupivacaine .In sitting position lumbar puncture will done using a 25 gauge needle (Exel) into the subarachnoid space L3-L4 in the midline just cephalad. After cerebrospinal fluid aspiration, 2.5 ml of 0.5% hyperbaric bupivacaine (Astrazeneca) will inject.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital, C operating room
Full name of responsible person
Shahryar Sane,Assistant Professor, Anesthesiologist
Street address
Modarres Avenue, Ershad Avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Street address
Ershad avenue, Imam Khomeini Hospital, Department of Anesthesiology
City
Urmia
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 of Urmia University of Medical Sciences