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Comparison of bleeding during anesthesia with isoflurane and sevoflurane in endoscopic nasal surgeries and tympanomastoidectomy

Protocol summary

Summary
Objectives: In ear, nose and throat surgeries, like all types of surgeries anesthesiologists play an important role in an accurate and uncomplicated operation. Sinus endoscopy and tympanoplasty can be performed without anesthesia but in most cases, local or general anesthesia are needed for patient and surgeon comfort and reduce the surgery complications which bleeding is the most common of them. Sevoflurane is a fairly new inhalation anesthetic. Although it is like other inhaled anesthetic agents such as isoflurane but there are differences between them, including the rise in heart rate in anesthetized with isoflurane that does not happen with sevoflurane. Because the combination of remifentanil and anesthetic gases is a proper method to controlled hypotension, we decided to compare these two drugs in sinus endoscopic surgery and tympanoplasty. Design: Block randomization, without placebo, trial phase 2, including ninety patients under sinus endoscopic surgery or tympanomastoidectomy Participants including major eligibility criteria: All the patients who underwent endoscopic sinus surgery or tympanomastoidectomy Intervention: Intervention 1. Sevoflurane, 1 MAC, inhalation, peri-operative Intervention 2. Isoflurane, 1 MAC, inhalation, peri-operative Main outcome measures: bleeding, blood pressure, heart rate, O2 saturation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306083289N6
Registration date: 2014-01-17, 1392/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Esmail Moshiri
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
dr_moshiri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of medical sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bleeding during anesthesia with isoflurane and sevoflurane in endoscopic nasal surgeries and tympanomastoidectomy
Public title
Comparison of isoflurane and sevoflurane in nasal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All the patients who underwent endoscopic sinus surgery or tympanomastoidectomy Exclusion criteria: 1. Age over 55 years 2. Patients with history of cardiovascular problems, hypertension, and COPD 3. Patients under anticoagulation treatment 4. Using tranquilizers 5. Patients with drug abuse
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
ninety patients candidate for nasal endoscopic surgeries and tympanoplasty divided into two equal groups using a randomized block.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
91-137-6

Health conditions studied

1

Description of health condition studied
Bleeding
ICD-10 code
Y60.0
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care( During surgical operation)

Primary outcomes

1

Description
Bleeding
Timepoint
In the end of surgery
Method of measurement
Quality grading that is recorded in patient's sheet

2

Description
Blood pressure
Timepoint
At the beginning of operation and every 15 minutes during surgery.
Method of measurement
Measure with mercury sphygmomanometer and record in patient's sheet

3

Description
Heart rate
Timepoint
At the beginning of operation and every 15 minutes during surgery.
Method of measurement
The number of heart beats per minute is calculated and recorded in the patient's sheet

4

Description
Arterial saturation of oxygen
Timepoint
At the beginning of operation and every 15 minutes during surgery.
Method of measurement
Measure with pulse oximeter and record in patient's sheet

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Inhalational Sevoflurane, chemical composition 1,1,1,3,3,3-hexafluoro-2-(fluoromethoxy)propane, marketed by Abbot Park, North Chicago, Illinois, which is used by 1 MAC, peri-operative.
Category
Treatment - Other

2

Description
Intervention 2: Inhalational Isoflurane, chemical composition 1-chloro-2,2,2-trifluoromethyl ether, marketed by Nicholas Piramal(I)London, which is used by 1 MAC, peri-operative.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Esmaeil Moshiri
Street address
Amirkabir Hospital. Parastar square. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice Chancellor for Research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
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,Vice Chancellor for Research
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 University of Medical Sciences
Full name of responsible person
Dr Esmaeil Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 1417 3641
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeil Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 1417 3641
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeil Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 1417 3641
Fax
Email
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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