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The comparison the effects of propofol and isoflurane on the gradient between arterial and end-tidal carbon dioxide pressure following one-lung ventilation in thoracic surgery.

Protocol summary

Summary
Purpose of the study: A double-blind, clinical trial, with block randomization design, on the comparison of the effects of propofol and isoflurane on the gradient between arterial and end-tidal carbon dioxide pressure following one-lung ventilation in thoracic surgery. Study population: ASA I and ASA II patients aged between 18 and 40 years, undergoing elective thoracotomy for lung surgery or cystectomy under OLV. Inclusion criteria: 1) Aged 18-75 years; 2) sustaining ASA I and ASA II; and 3) consent to thoracic surgery according to OLV under investigation. Exclusion criteria: 1) Liver failure; 2)ischemia or heart valve disease; 3) history of anesthesia; 4) obstructive pulmonary disease with limitation in end-stage; 5) patients with OLV less than 30 minutes; 6) patients whose breath count reached 12 at the onset of anesthesia and before one-lung ventilation; and 7) patients with HRCT, PFT, and pathological lesions in the left lung. Sample: 122. Study Intervention: Propofol and isoflurane anesthesia. The outcome of the study: Evaluation of end-tidal carbon dioxide pressure, arterial carbon dioxide pressure, and tidal blood pressure through capnography, pulse oximetry, and radial artery catheter, respectively, monitoring depth of anesthesia with BIS 10 and 20 minutes after the intervention, and comparison of the obtained results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015123013159N8
Registration date: 2016-01-12, 1394/10/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-12, 1394/10/22
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison the effects of propofol and isoflurane on the gradient between arterial and end-tidal carbon dioxide pressure following one-lung ventilation in thoracic surgery.
Public title
The comparison of effects of drug in thoracic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Aged 18-75 years; 2) sustaining ASA I and ASA II; and 3) consent to thoracic surgery according to OLV under investigation. Exclusion criteria: 1) Liver failure; 2)ischemia or heart valve disease; 3) history of anesthesia; 4) obstructive pulmonary disease with limitation in end-stage; 5) patients with OLV less than 30 minutes; 6) patients whose breath count reached 12 at the onset of anesthesia and before one-lung ventilation; and 7) patients with HRCT, PFT, and pathological lesions in the left lung.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.MUMS.fm.REC.1394.372

Health conditions studied

1

Description of health condition studied
One-lung ventilation in thoracic surgery
ICD-10 code
J98.8
ICD-10 code description
Other specified respiratory disorders

Primary outcomes

1

Description
Evaluation of end-tidal carbon dioxide pressure
Timepoint
10 and 20 minutes after intervention
Method of measurement
Capnography; mm Hg

Secondary outcomes

1

Description
Evaluation of arterial carbon dioxide pressure
Timepoint
10 and 20 minutes after intervention
Method of measurement
Pulse oximetry; mm Hg

Intervention groups

1

Description
Control group: 100 µg/kg/min anesthetic propofol before thoracic surgery
Category
Treatment - Drugs

2

Description
Intervention group: 0.01 µg/kg/min anesthetic isoflurane before thoracic surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem Hospital, Ahmadabad Avenue
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Shebani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Reza Sarifian Attar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Postal code
Phone
+98 51 3764 7230
Fax
Email
sharifiana@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2612
Fax
Email
sheybanish@mums.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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