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Comparison of general anesthesia and thoracic epidural anesthesia in diagnostic thoracoscopic operations

Protocol summary

Summary
Patients who need diagnostic thoracoscopy and can lie down in the lateral position in conscious status, will be randomized between two groups. The control group will be undergone the operation by general anesthesia and insertion of double lumen tracheal tube and the intervention group undergone the same operation by epidural anesthesia. After the operation the epidural catheter will be maintained for postoperative analgesia. These variables will be compared between the two groups: duration of operation, heart rate, minimum arterial oxygen saturation, pCO2 (minimum, maximum), respiratory rate (minimum, maximum), systolic and diastolic blood pressure (minimum, maximum), total hospital stay, total intensive care unit stay, need for mechanical ventilation after the operation, in hospital mortality. Our hypothesis is that there is no difference between the epidural and general anesthesia according to these variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050116473N2
Registration date: 2014-05-18, 1393/02/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of general anesthesia and thoracic epidural anesthesia in diagnostic thoracoscopic operations
Public title
Comparison of general anesthesia and thoracic epidural anesthesia in diagnostic thoracoscopic operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for thoracospy; ASA class I or II; 20-60 Y/O; ability to be in lateral position; little tracheal secretions; no need for preoperative mechanical ventilation Exclusion criteria: no consent for epidural anaesthesia; no cooperation for epidural anaesthesia; inability to perform epidural anaesthesia
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht
City
Tabriz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
92117

Health conditions studied

1

Description of health condition studied
Pleural effusion, not elsewhere classified
ICD-10 code
J90
ICD-10 code description
Pleurisy with effusion

2

Description of health condition studied
Pleural effusion in conditions classified elsewhere
ICD-10 code
J91
ICD-10 code description
Pleural effusion in conditions classified elsewhere

3

Description of health condition studied
Pneumothorax
ICD-10 code
J93
ICD-10 code description
Pneumothorax

4

Description of health condition studied
Other pleural conditions
ICD-10 code
J94
ICD-10 code description
Other pleural conditions

5

Description of health condition studied
Acute pulmonary insufficiency following thoracic surgery
ICD-10 code
J95.1
ICD-10 code description
Acute pulmonary insufficiency following thoracic surgery

Primary outcomes

1

Description
duration of operation
Timepoint
during the operation of each patient
Method of measurement
with a timer

2

Description
minimum and maximum heart rate
Timepoint
during the operation of each patient
Method of measurement
with an electrocardiograph

3

Description
minimum arterial oxygen saturation
Timepoint
during the operation of each patient
Method of measurement
with a digital pulse oxymeter

4

Description
minimum and maximum arterial pCO2
Timepoint
every half hour during the operation
Method of measurement
with arterial blood gas sampling

5

Description
minimum and maximum respiratory rate
Timepoint
during the operation of each patient
Method of measurement
with a respiratory rate monitor

6

Description
minimum and maximum systolic and diastolic blood pressure
Timepoint
during the operation of each patient
Method of measurement
by NIBP monitor

7

Description
duration of hospital stay
Timepoint
after the operation till discharge
Method of measurement
total hospital stay

8

Description
duration of ICU stay
Timepoint
after the operation till transfer to the ward
Method of measurement
total ICU stay

9

Description
duration of mechanical ventilation
Timepoint
after the operation till extubation
Method of measurement
total hours of need for mechanical ventilation

10

Description
in hospital mortality
Timepoint
after the operation till discharge
Method of measurement
report of death by the attending physician

Secondary outcomes

1

Description
need for conversion to general anesthesia
Timepoint
during the operation
Method of measurement
report of the conversion by the anesthesiologist

2

Description
pain after the operation
Timepoint
6 and 24 hours after the operation
Method of measurement
by visual analog scale

Intervention groups

1

Description
Standard general anesthesia with double lumen tracheal tube insertion in the control goup
Category
Treatment - Other

2

Description
Epidural anesthesia by insertion of thoracic epidural catheter and injection of Marcaine in the intervention group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Imam Reza hospital
Full name of responsible person
Ahmad Shaikloo
Street address
Thoracic surgery ward, Imam Reza hospital, Golgasht street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza rashidi
Street address
Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Beheshti Rouy
Position
Assistant professor of thoracic surgery
Other areas of specialty/work
Street address
Golgasht
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
s_beheshty@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davood Aghamohammadi
Position
Associate professor of anesthesiology
Other areas of specialty/work
Street address
Golgasht
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
daghamohamadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor of surgery
Other areas of specialty/work
Street address
Golgasht
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
fkakaei@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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