Protocol summary

Summary
In a double blinded randomized clinical trial, 154 patients scheduled for lower abdominal surgery (after receiving sufentanil 0.2 mcg/kg, propofol 2.5 mg/kg and atracurium 0.5 mg/kg) are anesthetized and intubated. Patients are in the age of 18-65, ASA I and II, are not pregnant and without prior history of cardiopulmonary and nervous system diseases, with no history of opioids, tranquilizers and theophyline use. Infusion of propofol 200 mcg/kg will be continued. Patients with hypotension which cause decreasing propofol dose or use of vasoactive agents or who needed more opioids during surgery, are excluded. At the end of surgery, infusion of propofol will be hold on after the beginning of spontaneous breathing and in one group aminophyline 1 mg/kg in 10 ml volume with distilled water will be injected intravenously during 2 minutes and in the other group only 10 ml distilled water will be injected. Heart rate, mean arterial blood pressure and oxygen saturation will be recorded every 2 minutes until extubation and then every 5 minutes till release from recovery ( by getting at least 8 points from Alderet score). Any other side effects (nausea, vomiting, hypotension, desaturation,...) will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812183520N1
Registration date: 2011-02-01, 1389/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-02-01, 1389/11/12
Registrant information
Name
Bijan Yazdi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 2003
Email address
yazdi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Aminophylline (vs. placebo) on the depth of anesthesia and recovery of propofol
Public title
Effect of Aminophylline on the depth of anesthesia and recovery of propofol
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18- 65, ASA I and II, scheduled for lower abdomen surgery, non pregnant, without any history of cardiac, pulmonary and nourologic disease, not using tranquilizers or opioids and theophyline group drugs. Exclusion criteria: hypotension during anesthesia that do not response to fluid therapy and need to decrease propofol infusion or need for using vasoactive drugs for treatment, need for more opioid during anesthesia.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 154
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
Arak University of Medical Sciences
Street address
Alam-ol-Hoda st., Shahid Shiroodi Ave.,
City
Arak
Postal code
3819693345
Approval date
2009-12-23, 1388/10/02
Ethics committee reference number
88-68-3

Health conditions studied

1

Description of health condition studied
general anesthesia
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics

Primary outcomes

1

Description
recovery time
Timepoint
once
Method of measurement
time from injection of drug or placebo to release from recovery

2

Description
extubation time
Timepoint
once
Method of measurement
time from injection of drug or placebo to extubation

Secondary outcomes

1

Description
oxygen saturation
Timepoint
every 2 minutes from injection of drug or placebo to extubation then every 5 minutes till release from recovery
Method of measurement
pulse oximeter

2

Description
heart rate
Timepoint
every 2 minutes from injection of drug or placebo to extubation then every 5 minutes till release from recovery
Method of measurement
pulse oximeter

3

Description
mean arterial pressure
Timepoint
every 2 minutes from injection of drug or placebo to extubation then every 5 minutes till release from recovery
Method of measurement
automated blood pressure recorder

4

Description
nausea and vomiting
Timepoint
as happens
Method of measurement
diagnosed by anesthetist

5

Description
dysrythmia
Timepoint
as happens
Method of measurement
electrocardiography

Intervention groups

1

Description
Injection of aminophyline, 1 mg/kg in 10 ml of distilled water, at the end of surgery when spontaneous breathing begins and propofol infusion stops.
Category
Prevention

2

Description
Injection of 10 ml of distilled water at the end of surgery when spontaneous breathing begins and propofol infusion stops.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Bijan Yazdi M.D
Street address
Department of anesthesia, Vali-e-Asr hospital, Vali - e - asr sq.
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saeed Changizi Ashtiani
Street address
Pardis Site, Basij sq.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak Univarsity of Medical Sciences
Full name of responsible person
Dr. Bijan Yazdi
Position
Assistant Professor of anesthesiology
Other areas of specialty/work
Street address
Department of anesthesia, Vali - e- Asr hospital, Vali - e- Asr sq
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
yazdi@arakmu.ac.ir , yazdibijan@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak Univarsity of Medical Sciences
Full name of responsible person
De. Bijan yazdi
Position
Assistant Professor of anesthesiology
Other areas of specialty/work
Street address
Department of anesthesia,Vali - e- Asr hospital, Vali - e- Asr sq
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
yazdi@arakmu.ac.ir , yazdibijan@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak Univarsity of Medical Sciences
Full name of responsible person
Dr. Bijan Yazdi
Position
Assistant Professor of anesthesiology
Other areas of specialty/work
Street address
Department of anesthesia,Vali - e- Asr hospital, Vali - e- Asr sq
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
yazdi@arakmu.ac.ir , yazdibijan@hotmail.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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