History
# Registration date Revision Id
2 2021-07-06, 1400/04/15 189846
1 2021-04-01, 1400/01/12 176868
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  • Protocol summary

    Comparing the Effect of two anesthesia methods by Remifentanil and Dexmedetomidine on intra operative bleeding and surgical field Quality during Rhinoplasty surgery
    Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
    مقایسه ی تاثیر دو روش بیهوشی با رمی فنتانیل و دکسمدتومیدین بر میزان خونریزی حین عمل و میزان کیفیت فیلد جراحی در اعمال جراحی زیبایی بینی
    مقایسه ي تاثیر رمی فنتانیل و دکسمدتومیدین بر رضایتمندی جراح از فیلد جراحی و میزان خونریزی در اعمال جراحی زیبایی بینی
    In the Intervention group one ,patients will receive a bolus dose of 1 micrograms per kilogram dexmedetomidine ( PFIZER,USA)and infusion starts 0.4-0.8 microgram per kilogram .In the dexmedetomidine group, the dose of propofol (B. Braun Melsungen Ag)from the beginning to the end of the surgery will be 100 micrograms per kilogram. In the Intervention group two, a bolus dose of normal saline is injected as a placebo 20 minutes before induction. After induction in the remifentanil group, remifentanil (EXIR,IRAN) infusion of 0.25 micrograms is started.The dose of propofol (B. Braun Melsungen Ag) after induction in the first 20 minutes are 150 micrograms per kilogram, in the second 20 minutes 120 micrograms per kilogram and then until the end of surgery 100 micrograms per kilogram.
    In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation. In the Intervention group two simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
    در گروه مداخله یک بیماران دوز بولوس 1 میکروگرم بر کیلوگرم دکسمدتومیدین( PFIZER,USA) دریافت خواهند نمود و بعد از اینداکشن با دوز 0.4-0.8 میکروگرم شروع می شود. داروی نگهدارنده بیهوشی در گروه دکسمدتومیدین از ابتدا تا انتهای عمل جراحی دوز پروپوفول (B. Braun Melsungen Ag)100 میکروگرم بر کیلوگرم خواهد بود. در گروه مداخله دو 20 دقیقه قبل از اینداکشن دوز بولوس نرمال سالین به عنوان پلاسبو تزریق می شود. بعد از اینداکشن در گروه رمی فنتانیل (EXIR,IRAN)اینفیوژن رمی فنتانیل 0.25 میکروگرم شروع می شود. در گروه رمی فنتانیل دوز پروپوفول (B. Braun Melsungen Ag)بعد از اینداکشن در 20 دقیقه اول 150 میکروگرم بر کیلوگرم، در 20 دقیقه دوم 120 میکروگرم بر کیلوگرم و در ادامه تا انتهای عمل جراحی 100 میکروگرم بر کیلوگرم خواهد بود.
    در گروه مداخله یک بیماران 1 میکروگرم بر کیلوگرم دکسمدتومیدین( PFIZER,USA) در طول 20 دقیقه دریافت خواهند نمود و همزمان با شروع اینداکشن با دوز 0.6 میکروگرم بر کیلو گرم شروع می شود.و تا پایان عمل ادامه می یابد. در گروه مداخله دو همزمان با شروع القاي بیهوشی ، در گروه رمی فنتانیل (EXIR,IRAN)اینفیوژن رمی فنتانیل 0.25 میکروگرم شروع می شود.وتا پایان عمل ادامه یافت.
    Intraoperative bleeding
    Intraoperative bleeding, pain,surgeon satisfaction
    خونریزی حین عمل
    خونریزی حین عمل، درد ، رضایتمندی جراح
  • General information

    empty
    A more accurate record of the study method
    empty
    ثبت دقیق تر روش کار مطالعه
    Comparing the two anesthesia methods on intra operative bleeding during Rhinoplasty surgery
    Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
    مقایسه دو روش بیهوشی بر میزان خونریزی حین عمل در اعمال جراحی زیبایی بینی
    مقایسه ي تاثیر رمی فنتانیل و دکسمدتومیدین بر رضایتمندی جراح از فیلد جراحی و میزان خونریزی در اعمال جراحی زیبایی بینی
    Comparing the Effect of two anesthesia methods by Remifentanil and Dexmedetomidine on intra operative bleeding and surgical field Quality during Rhinoplasty surgery
    Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
    مقایسه ی تاثیر دو روش بیهوشی با رمی فنتانیل و دکسمدتومیدین بر میزان خونریزی حین عمل و میزان کیفیت فیلد جراحی در اعمال جراحی زیبایی بینی
    مقایسه ي تاثیر رمی فنتانیل و دکسمدتومیدین بر رضایتمندی جراح از فیلد جراحی و میزان خونریزی در اعمال جراحی زیبایی بینی
    داروها توسط یک پرستار که از نوع مطالعه بی اطلاع است با برچسب A در گروه دکسمدتومیدین و برچسب B در گروه رمی فنتانیل تهیه می شود و در اختیار فردی که از تخصصیص گروهها بی اطلاع است جهت تزریق قرار داده میشود . فردی که بیماران و رضایتمندی بیماران را در انتهای مطالعه ارزیابی می کند نیز از تخصیص گروههای مطالعه بی اطلاع است .
    داروها توسط یک پرستار که از نوع مطالعه بی اطلاع است با برچسب A در گروه دکسمدتومیدین و برچسب B در گروه رمی فنتانیل تهیه می شود و در اختیار فردی که از تخصصیص گروهها بی اطلاع است جهت تزریق قرار داده میشود . فردی که بیماران و رضایتمندی بیماران را در انتهای مطالعه ارزیابی می کند نیز از تخصیص گروههای مطالعه بی اطلاع است .
  • Primary outcomes

    #1
    empty
    Post operative pain
    empty
    درد پس از عمل
    empty
    At arrival to the recovery room and at, 45,30,15 minutes
    empty
    در بدو ورود به ریکاوری در زمان بیداری کامل ،45،30،15 دقیقه
    empty
    Visual analogue Scale
    empty
    معیار تصویری اندازه گیری درد
  • Intervention groups

    #1
    Intervention group: In the Intervention group one, patients will receive a bolus dose of 1 micrograms per kilogram dexmedetomidine ( PFIZER,USA)and infusion starts 0.4-0.8 microgram per kilogram .In the dexmedetomidine group, the dose of propofol (B. Braun Melsungen Ag)from the beginning to the end of the surgery will be 100 micrograms per kilogram.
    Intervention group: In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation..
    گروه مداخله: در گروه مداخله یک بیماران دوز بولوس 1 میکروگرم بر کیلوگرم دکسمدتومیدین( PFIZER,USA) دریافت خواهند نمود و بعد از اینداکشن با دوز 0.4-0.8 میکروگرم شروع می شود. داروی نگهدارنده بیهوشی در گروه دکسمدتومیدین از ابتدا تا انتهای عمل جراحی دوز پروپوفول (B. Braun Melsungen Ag)100 میکروگرم بر کیلوگرم خواهد بود.
    گروه مداخله: در گروه مداخله یک بیماران 1 میکروگرم بر کیلوگرم دکسمدتومیدین( PFIZER,USA) در طول 20 دقیقه دریافت خواهند نمود و همزمان با شروع اینداکشن با دوز 0.6 میکروگرم بر کیلو گرم شروع می شود.و تا پایان عمل ادامه می یابد.
    #2
    Intervention group: In the Intervention group two, a bolus dose of normal saline is injected as a placebo 20 minutes before induction. After induction in the remifentanil group, remifentanil (EXIR,IRAN) infusion of 0.25 micrograms is started.The dose of propofol (B. Braun Melsungen Ag) after induction in the first 20 minutes are 150 micrograms per kilogram, in the second 20 minutes 120 micrograms per kilogram and then until the end of surgery 100 micrograms per kilogram.
    Intervention group: In the Intervention group two:Simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
    گروه مداخله: در گروه مداخله دو 20 دقیقه قبل از اینداکشن دوز بولوس نرمال سالین به عنوان پلاسبو تزریق می شود. بعد از اینداکشن در گروه رمی فنتانیل (EXIR,IRAN)اینفیوژن رمی فنتانیل 0.25 میکروگرم شروع می شود. در گروه رمی فنتانیل دوز پروپوفول (B. Braun Melsungen Ag) بعد از اینداکشن در 20 دقیقه اول 150 میکروگرم بر کیلوگرم، در 20 دقیقه دوم 120 میکروگرم بر کیلوگرم و در ادامه تا انتهای عمل جراحی 100 میکروگرم بر کیلوگرم خواهد بود.
    گروه مداخله: همزمان با شروع القاي بیهوشی ، در گروه رمی فنتانیل (EXIR,IRAN)اینفیوژن رمی فنتانیل 0.25 میکروگرم شروع می شود.وتا پایان عمل ادامه یافت.
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Seed Basir Hashemi
    Full name of responsible person - Persian: دکتر سید بصیر هاشمی
    Street address - English: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
    Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134844119
    Phone: +98 71 3647 4270
    Fax:
    Email: masihifarzaneh@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Abbas Rezaianzadeh
    Full name of responsible person - Persian: دکتر عباس رضاییان زاده
    Street address - English: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
    Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134844119
    Phone: +98 71 3647 4270
    Fax:
    Email: vcrdep@sums.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
Design
Double-blind randomized clinical trial
Settings and conduct
The drugs are prepared in the operating room by a nurse who is unaware of the type of study with label A in the dexmedetomidine group and label B in the remifentanil group and are given to a person who is unaware of the specialization of the groups for injection. The person assessing patients and patient satisfaction at the end of the study is also unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-45 y/o, Patients undergoing rhinoplasty surgery Exclusion criteria: Patients with liver dysfunction, Renal dysfunction, Any known allergy or hypersensitivity to study drugs, analgesics abuse, opium addiction, Diabetes , Hemorrhagic disease, Using anticoagulants, Cerebrovascular disease, Heart block, Cardiovascular disease.
Intervention groups
In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation. In the Intervention group two simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
Main outcome variables
Intraoperative bleeding, pain,surgeon satisfaction

General information

Reason for update
A more accurate record of the study method
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N112
Registration date: 2021-04-01, 1400/01/12
Registration timing: prospective

Last update: 2021-07-11, 1400/04/20
Update count: 1
Registration date
2021-04-01, 1400/01/12
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-23, 1400/02/03
Expected recruitment end date
2021-06-24, 1400/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
Public title
Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 years old Patients undergoing rhinoplasty surgery time of surgery is 7-10 days before menstruation time
Exclusion criteria:
Patients with liver dysfunction Renal dysfunction Any known allergy or hypersensitivity to study drugs Abuse of analgesics and any addiction to opioid, Diabetes mellitus Hemorrhagic disease Using anticoagulants Cerebrovascular disease Heart block Cardiovascular disease Morbid obesity Females whom experience nausea and vomiting in their menstrual cycle Revision rhinoplasty surgery
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is based on permutation block randomization method with block size 6 by using the site www.sealedenvelope.com and Seed number: 266608829014794.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs are prepared by a nurse who is unaware of the type of study with label A in the dexmedetomidine group and label B in the remifentanil group and are given to a person who is unaware of the specialization of the groups for injection. The person assessing patients and patient satisfaction at the end of the study is also unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.SUMS.MED.REC.1399.241

Health conditions studied

1

Description of health condition studied
Rhinoplasty surgery
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery

Primary outcomes

1

Description
Amount of intraoperative bleeding
Timepoint
At the end of the surgery
Method of measurement
Observasion

2

Description
Post operative pain
Timepoint
At arrival to the recovery room and at, 45,30,15 minutes
Method of measurement
Visual analogue Scale

Secondary outcomes

1

Description
Patients’ satisfactions
Timepoint
After injection of intervention drugs in the recovery room and surgery ward
Method of measurement
Likert Scale

2

Description
Surgeon’ satisfactions
Timepoint
At the end of the surgery
Method of measurement
Likert Scale

Intervention groups

1

Description
Intervention group: In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation..
Category
Prevention

2

Description
Intervention group: In the Intervention group two:Simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Maryam Nemati
Street address
Khalili Educational Hospital, Khalili Street -
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3612 2313
Email
khalili.hospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Abbas Rezaianzadeh
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
Nemati.mrym@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Cardio-anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
joybarr@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in English Teaching, BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against the policies of the center.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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