Protocol summary

Summary
The aim of this study was to compare the effect of Flumazenil and Aminophylline on cognitive and neuromotor emergence after Isoflurane based anesthesia. To conduct this randomized, placebo-controlled, double-blind study, 90 ASAI-II patients who were scheduled to undergo orthopedic surgery under general anesthesia with nitrous oxide and Isoflurane were selected. Midazolam 0.03mg/kg and Morphine 2mg/kg was administered as premedication. Anesthesia was induced with Sodium Thiopental 5-6mg/kg and Atracurium 0/5-0/6mg/kg and controlled ventilation was maintained with 50%N2O+50%O2+Isoflurane. Isoflurane and N2O were discontinued at the end of surgery. A coded ampule containing either 1mg Flumazenil or Aminophylline 2mg/kg or an equal volume (10cc) of saline was administered when the patient began to awaken. Vigilance was assessed by eye opening(spontaneous or command), limb movement (spontaneous or command), showing tongue on command, recall of age, recall of date of birth, recall of telephone number, simple arithmetic (2*3,4+7,etc.). Neurological recovery was evaluated by the papillary light reflex, the eyelash reflex and the absence of Babinski reflex. The following outcomes were measured at 5, 10, 20, 30, 40, 50 and 60 minutes after the injection of the test drug.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138801261815N1
Registration date: 2009-10-10, 1388/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-10-10, 1388/07/18
Registrant information
Name
Laleh Dehghanpisheh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1636 3955
Email address
ldehghan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2007-06-01, 1386/03/11
Expected recruitment end date
2008-07-01, 1387/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of Flumazenil versus Aminophylline on cognitive and neuromotor emergence after Isoflurane anesthesia.
Public title
A comparative study of Flumazenil versus Aminophylline on cognitive and neuromotor emergence after Isoflurane anesthesia.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: ASAI-II, age 14 to 65y/o, operation less than 3 hours Exclusion criteria: benzodiazepine ingestion within two weeks prior to the study, chronic benzodiazepine use, presence of respiratory and cardiovascular diseases, pregnancy, motor system dysfunction, renal and liver diseases, sensitivity to Flumazenil or benzodiazepine, ASAIII-IV, substance abuse or psychiatric problems
Age
From 14 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Midazolam 0.03mg/kg and Morphine 2mg/kg was administered as premedication. Anesthesia was induced with sodium thiopental 5-6mg/kg and atracurium 0/5-0/6mg/kg and controlled ventilation was maintained with 50%N2O+50%O2+Isoflurane. Isoflurane and N2O were discontinued at the end of surgery . A coded ampule containing either 1mg Flumazenil or Aminophylline 2mg/kg or an equal volume (10cc) of saline was administered when the patient began to awaken.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Central building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
empty
Ethics committee reference number
3749-86

Health conditions studied

1

Description of health condition studied
Volatile anesthetics
ICD-10 code
Y48.0
ICD-10 code description
Inhaled anaesthetics

Primary outcomes

1

Description
Level of consciousness
Timepoint
5-10-20-40-50-60minute after injection of drugs
Method of measurement
Asking from the patients

2

Description
Neuromotor emergence
Timepoint
5-10-20-40-50-60minute after injection of drugs
Method of measurement
Examination

Secondary outcomes

empty

Intervention groups

1

Description
Flumazenil 1mg was administered after discontinuation of Isoflurane
Category
Treatment - Drugs

2

Description
Aminophylline 2mg/kg was administered after discontinuation of Isoflurane
Category
Treatment - Drugs

3

Description
Normal saline, 10cc was injected after discontinuation of Isoflurane
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Laleh dehghanpisheh
Street address
Anesthesiology ward, Chamran hospital, Chamran Blvd.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of Medical Sciences
Full name of responsible person
Dr. Afshin Amini
Street address
Shiraz university of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Asef Parviz Kazemi
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Chamran hospital
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
+98 71 1230 7072
Email
ap-kazemi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Asef Parviz Kazemi
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Chamran hospital, lChamran Blvd.
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
+98 71 1230 7072
Email
ap-kazemi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Laleh Dehghanpisheh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Faghihi hospital -Aesthesiology ward
City
Shiraz
Postal code
Phone
+98 71 1231 8072
Fax
+98 71 1230 7072
Email
ldehgha@sums.ac.ir lalehdehghanpisheh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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