Assessment of different doses of aminophylline on decreasing recovery time and EEG during recovery based on BFI (Brain Function Index) after Isoflurane anesthesia in Trunk surgery.
This study evaluates effects of 1 and 5 mg/kg Aminophylline injection on rapidity of brain awareness (awakening) and lowering recovery time based on EEG and prevalence of adverse effects of Aminophylline on 102 patients with following condition:
Inclusion criteria:patients with ASA, class 1 & 2;patients between 15 to 70 years old;weight more than 40 kg.Exclusion criteria :patients with asthma( or similar diseases) in whom aminophylline is needed during surgery or during recovery; patients with liver failure or cardiac failure ( cor pulmonale);neurologic or psychologic diseases which can cause seizure;drugs which affect brain activity including tranquilizers and CNS stimulants;serum albumin less than 2gr/dl;aminophylline injection during surgery for any reason;labetalol or other similar drugs injection (affecting cardiovascular system) during surgery for any reason.
This randomized trial take places on patients undergoing abdominal surgery with general anesthesia and tracheal intubation maintained by Isoflurane.
At the end of surgery after discontinuing Isoflurane, all patients divided in three groups:
Group 1: Aminophylline 1 mg/ kg
Group 2: Aminophylline 5 mg/kg
Group 3: Placebo/witness
EEG is monitored based on BFI during recovery time in all groups.
We compare rapidity of awareness from anesthesia , rapidity of EEG changes based on BFI, and possible side effects in all three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403073773N11
Registration date:2015-08-02, 1394/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of different doses of aminophylline on decreasing recovery time and EEG during recovery based on BFI (Brain Function Index) after Isoflurane anesthesia in Trunk surgery.
Public title
Assessment of Aminophylline on decreasing recovery time after general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing elective Trunk surgery with general anesthesia ;patients with ASA, class 1 & 2;patients between 15 to 70 years old;weight more than 40 kg.Exclusion criteria :patients with asthma
( or similar diseases) in whom aminophylline is needed during surgery or during recovery; patients with liver failure or cardiac failure ( cor pulmonale);neurologic or psychologic diseases which can cause seizure;drugs which affect brain activity including tranquilizers and CNS stimulants (eg. Amphetamine);serum albumin less than 2gr/dl ( which lowers drug- plasma protein binding and increases drug effects);aminophylline injection during surgery for any reason;labetalol or other similar drugs injection (affecting cardiovascular system) during surgery for any reason.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
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
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
Ghods cross, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-02-16, 1392/11/27
Ethics committee reference number
9011174001
Health conditions studied
1
Description of health condition studied
brain signals
ICD-10 code
G96.8
ICD-10 code description
Other specified disorders of central nervous system
2
Description of health condition studied
Recovery time
ICD-10 code
G96.9
ICD-10 code description
Disorder of central nervous system, unspecified
Primary outcomes
1
Description
Patient's stay time at PACU (Post Anesthesia Care Unit)
Timepoint
From discontinuing of anesthesia till discharge of PACU
Method of measurement
minute
Secondary outcomes
1
Description
Brain signals
Timepoint
During anesthesia and recovery time
Method of measurement
BFI (Brain Function Index)
Intervention groups
1
Description
In group 1, after cleaning of forehead with alcohol and adhesion of leads, EEG monitoring started based on BIS.
All patients received midazolam 60 mic g/kg and fentanyl 2 mic g/ kg as pre-medication. Induction of anesthesia performed by thiopental 5mg/kg and muscle relaxation with atracurium 0.5 mg/ kg followed by tracheal intubation.
Anesthesia maintained by Isoflurane in order to remains BIS between 40 to 60.
In order to maintain 90-95% twitch inhibition, atracurium injected during surgery.
At the end of surgery and discontinuation of Isoflurane , aminophylline 1 mg/ kg injected intravenously. EEG monitored based on BIS during recovery period. Rapidity of awakening from anesthesia , rapidity of increasing brain waves based on BSI and possible side effects will be recorded.
Category
Other
2
Description
In group 2, after cleaning of forehead with alcohol and adhesion of leads, EEG monitoring started based on BIS.
All patients received midazolam 60 mic g/kg and fentanyl 2 mic g/ kg as pre-medication. Induction of anesthesia performed by thiopental 5mg/kg and muscle relaxation with atracurium 0.5 mg/ kg followed by tracheal intubation.
Anesthesia maintained by Isoflurane in order to remains BIS between 40 to 60.
In order to maintain 90-95% twitch inhibition, atracurium injected during surgery.
At the end of surgery and discontinuation of Isoflurane , aminophylline 5 mg/ kg injected intravenously. EEG monitored based on BIS during recovery period. Rapidity of awakening from anesthesia , rapidity of increasing brain waves based on BSI and possible side effects will be recorded.
Category
Other
3
Description
In group 3, after cleaning of forehead with alcohol and adhesion of leads, EEG monitoring started based on BIS.
All patients received midazolam 60 mic g/kg and fentanyl 2 mic g/ kg as pre-medication. Induction of anesthesia performed by thiopental 5mg/kg and muscle relaxation with atracurium 0.5 mg/ kg followed by tracheal intubation.
Anesthesia maintained by Isoflurane in order to remains BIS between 40 to 60.
In order to maintain 90-95% twitch inhibition, atracurium injected during surgery.
At the end of surgery and discontinuation of Isoflurane ,Placebo injected intravenously. EEG monitored based on BIS during recovery period. Rapidity of awakening from anesthesia , rapidity of increasing brain waves based on BSI and possible side effects will be recorded.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Farsad Imani
Street address
Hasanabad Sq., Imam Khomeini St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Medical school
Full name of responsible person
Dr Farsad Imani
Street address
Ghods cross, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Medical school
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Farsad Imani
Position
Professor assistant
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
imanifar@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farsad Imani
Position
professr asistant
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
imanifar@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farsad Imani
Position
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)