Protocol summary

Summary
• Objectives: Comparison of the effects of remifentanil and dexmedetomidine on recovery profile of patients after hysterectomy operation under anesthesia with venous propofol • Design: patients referring to the Firozgar hospital who are candidate for hysterectomy provided informed consent will be randomly assigned into two groups of dexmedetomidine and remifentanil. Study is phase 1/2, double-blinded and single center. • Setting and conduct: in this double-blinded randomized clinical trial, patients candidate for hysterectomy will be recruited according to the inclusion and exclusion criteria. All patients will sign informed consent forms. Anesthesia induction will be performed and the patients will receive 1 µg/kg of dexmedetomidine in 15 minutes and then 2 µg/kg/hour in the dexmedetomidine group and remifentanil 1 µg/kg/minute in the remifentanil group as infusion until the end of operation. • Participants including major eligibility criteria: patients candidate for elective hysterectomy operation in Firozgar hospital with ASA I-II grade provided informed consent are included. Patients above 70 years of age, emergency operation, patients with cardiopulmonary, renal, hepatic, diabetes, hypertension, obesity, difficult airway, lactating women, sleep apnea and psychological diseases will be excluded. • Intervention: drugs remifentanil and dexmedetomidine • Main outcome measures: anesthesia and operation duration, ETCO2, extubation time, recovery time, bradycardia, hypotension and Aledret scale

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017102731487N6
Registration date: 2017-11-20, 1396/08/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Iran University of Medical Sciences
Expected recruitment start date
2017-10-31, 1396/08/09
Expected recruitment end date
2018-04-23, 1397/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of remifentanil and dexmedetomidine on recovery profile of patients after hysterectomy operation under anesthesia with venous propofol
Public title
Comparison of the effects of two anesthetics on recovery profile of patients after hysterectomy operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for elective hysterectomy operation in Firozgar hospital; ASA I-II grade; informed consent Exclusion criteria: patients above 70 years of age; emergency operation; patients with cardiopulmonary disease; renal disease; hepatic disease; diabetes; hypertension; obesity; difficult airway; lactating women; sleep apnea; psychological diseases
Age
From 2 days old to 70 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be randomly allocated into two groups using block randomization method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
15459-13487
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.IUMS.FMD.REC1396.130417

Health conditions studied

1

Description of health condition studied
Hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)

Primary outcomes

1

Description
Consciousness
Timepoint
After recovery
Method of measurement
Aldrete questionnaire

Secondary outcomes

1

Description
Hemodynamic parameters
Timepoint
Every two hours from beginning of the operation and after the operation
Method of measurement
Barometer

Intervention groups

1

Description
Intervention group 1: 1 µg/kg of dexmedetomidine in 15 minutes and then 2 µg/kg/hour till the end of operation
Category
Treatment - Drugs

2

Description
Intervention group 2: 1 µg/kg/minute of remifentanil until end of the operation
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Dr Faranak Rokhtabnak
Street address
Behafarin st., Karim Khan Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Office of Vice-chancellor for Research, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Faranak Rokhtabnak
Position
Faculty member
Other areas of specialty/work
Street address
Firouzgar hospital, Behafarin st., Karim Khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1201
Fax
Email
rkhtbnk@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Faranak Rokhtabnak
Position
Faculty member
Other areas of specialty/work
Street address
Firouzgar hospital, Behafarin st., Karim Khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1201
Fax
Email
rkhtbnk@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Faranak Rokhtabnak
Position
Faculty member
Other areas of specialty/work
Street address
Firouzgar hospital, Behafarin st., Karim Khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1201
Fax
Email
rkhtbnk@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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