The effect of low thoracic epidural anesthesia combined with total intravenous anesthesia on dose requirement for induction and monitoring of depth of anesthesia guided by bispectoral index in patients under upper abdomen surgeries: randomized clinical trial
The purpose of this randomized trial is to evaluate the effect of thoracic epidural anesthesia combined with total intravenous anesthesia on dose requirement for induction &BIS in upper abdominal surgeries. A total of 40 patients with ASA (American Society of Anesthegiologist)1&2class, will be randomly located in two groups (intervention & control). After insertion of epidural catheter, patients receive bupivacaine 0.25% 0.7ml/m/seg for 10 segments. After complete of block, induction will be started with 1mg/s protocol infusion. When BIS (BIS PECTORAL INDEX) <50, patient will receive cisatra 0.15ml/kg & will be intubated .Then maintenance will be by propofol & remifentanyl infusion. In control group, patients will receive normal saline with the same volume in epidural space. At the end of surgery, drugs infusion will be discontinued. After estuation & reverse, patient will be transferred to recovery. Up to 30 minutes of surgery, heart rate, blood pressure, BIS, propofol dose will be recorded and compared between two groups.
TIVA (total intra venous anesthesia); BIS (Bispectral index); MAC (minimal alveolar concentration)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111074731N9
Registration date:2012-03-03, 1390/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Hamze Hosseinzade
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7055
Email address
hosseinz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice-chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low thoracic epidural anesthesia combined with total intravenous anesthesia on dose requirement for induction and monitoring of depth of anesthesia guided by bispectoral index in patients under upper abdomen surgeries: randomized clinical trial
Public title
The effect of thoracic epidural combined with total intravenous anesthesia on dose requirement for induction of anesthesia & bis pectoral index
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Adult patients, belonging to ASA 1&2 class; undergoing elective upper abdomen surgeries. Exclusion criteria: vertebral abnormality; neurologic disorders; cardio vascular diseases; Hgb <12; renal or hepatic failure; chest trauma; Allergy to local anesthetics; Plt <100000; Coagulopathy, βblockers.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research vice-chancellor of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences, Golgasht
City
Tabriz
Postal code
Approval date
2011-06-28, 1390/04/07
Ethics committee reference number
5/4/2756
Health conditions studied
1
Description of health condition studied
BIS changes due to thoracic epidural anesthesia
ICD-10 code
T66 -T78
ICD-10 code description
Other and unspecified effects of external causes
2
Description of health condition studied
anesthesia drug dose changes due to thoracic epidural
ICD-10 code
T66 - T78
ICD-10 code description
Other and unspecified effects of external causes
Primary outcomes
1
Description
Oxygen Saturation
Timepoint
before epidural, after epidural, before pre med, 3min after pre med, pre induction, post induction, after intubation, each 5min after surgery
Method of measurement
pulse oxymetry devices
2
Description
Mean arterial blood pressure
Timepoint
before epidural, after epidural, before pre med, 3min after pre med, pre induction, post induction, after intubation, each 5min after surgery
Method of measurement
with automatic cuff
3
Description
BIS
Timepoint
before epidural, after epidural, before pre med, 3min after pre med, pre induction, post induction, after intubation, each 5min after surgery
Method of measurement
BIS devices
4
Description
Propofol dose for induction & maintenance of anesthesia
Timepoint
Afer intubation, after extubation
Method of measurement
Infusion pump
5
Description
heart rate
Timepoint
before epidural, after epidural, before pre med, 3min after pre med, pre induction, post induction, after intubation, each 5min after surgery
Method of measurement
continuous ECG monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after epidural catheter insertion marcaine 0.25%,0.7ml/m/seg for 10 segments will be adminstered
Category
Other
2
Description
Control group: after epidural catheter insertion ,normal saline with same volume of marcaine will be adminstered
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Hosseinzade Hamze
Street address
Golgasht
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice-chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Science, Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Position
asociated professor
Other areas of specialty/work
Street address
Golgasht
City
Tabriz
Postal code
Phone
00894113855002
Fax
Email
hamzeh1338@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Position
Asociated professor
Other areas of specialty/work
Street address
Golgasht
City
Tabriz
Postal code
Phone
+98 41 1385 5002
Fax
Email
hamze1338@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)