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The effects of Aminophyllin on recovery duration, postoperative shivering and PONV with elective general surgery

Protocol summary

Summary
The aim of this project is determination the effects of Aminophyllin on decrease recovery duration, postoperative shivering and PONV with elective general surgery. It was a randomized, double-blind, clinical trial. After obtaining written informed consent from all patients, 88 patients scheduled for elective general surgery Will enter between 18 to 70 yr of aged with American Society of Anesthesiologists (ASA) physical status I or II. Patients with a history of cardiovascular, pulmonary, or thyroid disease; dysautonomia; fever; aminophylline intake within a day before surgery;and who received transplants will leave from this study. The patients will randomly divided into an aminophylline group (n = 44) and a saline control group (n = 44) using a computer- generated randomization list. For interventiont group 4 mg/ kg aminophylline in 10 mL of saline is diluted and for control group 10 mL of saline is given before surgery. The same way will induct anesthesia. Vital signs, duration of recovery, the degree of shivering in recovery and need to treatment of shivering, nausea and vomiting will be meaured and record in recovery and 6, 24 houre after surgery. The same: 0 = not shivering; 1 = not visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body، without nausea = 0; mild nausea = 1; moderate nausea = 2; severe nausea= 3being or not vomiting recorded and the results will be analyzed using statistical tests.

General information

Acronym
Aminophyllin on postoperative shivering
IRCT registration information
IRCT registration number: IRCT2017022631642N1
Registration date: 2017-02-26, 1395/12/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Mohadese Esmailnejad
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3427 2643
Email address
m.esmaeil@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Aminophyllin on recovery duration, postoperative shivering and PONV with elective general surgery
Public title
The effects of Aminophyllin on recovery duration, postoperative shivering and PONV with elective general surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Patients with a history of cardiovascular, pulmonary, or thyroid disease; dysautonomia; fever; aminophylline intake within a day before surgery; and who received transplant, will leave from this study. All patientsl will enter referred for elective general surgery to Imam Khomeini hospital in Ardebil.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, Daneshgah st.
City
Ardabil
Postal code
53141_56198
Approval date
2016-12-11, 1395/09/21
Ethics committee reference number
IR.ARUMS.REC.1395.91

Health conditions studied

1

Description of health condition studied
Postoperative shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Shivering
Timepoint
At the time of recovery
Method of measurement
Scale: 0 = no shivering; 1 = no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body.

Secondary outcomes

1

Description
Nausea
Timepoint
At the time of recovery, 6 and 24 hours after surgery.
Method of measurement
Scale: no nausea = 0; mild nausea = 1; moderate nausea = 2; severe nausea= 3

Intervention groups

1

Description
4 mg kg aminophylline in 10 mL of saline is diluted and infusion before surgery. Vital signs, duration of recovery, the degree of shivering and need to treatment shiveringin in recovery, nausea in recovery and 6,24 houre after surgery will be meaured and record .
Category
Treatment - Drugs

2

Description
Ten mL of saline is given before surgery Vital signs, duration of recovery, the degree of shivering and need to treatment shiveringin in recovery, nausea in recovery and 6,24 houre after surgery will be meaured and record . .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital in Ardebil
Full name of responsible person
Mohadeseh Esmailnejad
Street address
Ardebil bacij Ave
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr. Akbar Pirzadeh
Street address
Ardebil University of Medical Sciences, Daneshgah St.
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil 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
Ardebil University of Medical Sciences
Full name of responsible person
Mohadeseh Esmailnejad
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah St.
City
Ardebil
Postal code
Phone
+98 44 3427 2643
Fax
Email
m.esmaeil@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr. Masod Entezari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah St.
City
Ardebil
Postal code
Phone
+98 45 3352 2083
Fax
Email
m.entezari@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Mohadeseh Esmailnejad
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah St.
City
Ardebil
Postal code
Phone
Fax
Email
m.esmaeil@arums.ac.ir
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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