The aim of study is prevention or decrease of hemodynamic changes in laparosopic surgery.If patients have written informed consent ;ASA physical status I and II ;20-65 years old ;BMI less than 30 kg/m2 and no opioids addiction , 40 patients scheduled for laparoscopic cholesystectomy with general anaesthesia are divided into two groups to recieve infusion of either dexmedetomidine or remifentanile. uncontrolled hemodynamic chenges during surgery and open cholecystectomy are excluded from the study.
Blood pressure and heart rate are measured every 5 min and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010916151N1
Registration date:2014-12-29, 1393/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-29, 1393/10/08
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of dexmedetomidine and remifentanyle on blood pressure and heart rate in patients undergoing laparoscopic cholecystectomy
Public title
Effects of dexmedetomidine on blood pressure and heart rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent ;ASA physical status I and II ;20-65 years old ;BMI less than 30 kg/m2 ; Patients scheduled for elective laparoscopic cholecystectomy with general anesthesia ;Do not have respiratory disease and cardiac dysfunction and liver disease and renal disease and neuropathology and coagolopathy disease and uncontrolled hypertention ;Do not use of betablocker drugs and psycoactive drugs and analgesice drugs and opioid adiction .
Exclusion criteria:
uncontrolled hemodynamic chenges during surgery;open cholecystectomy
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Iran University of Medical Sciences
Street address
Hemat highway
City
Tehran
Postal code
Approval date
2014-03-25, 1393/01/05
Ethics committee reference number
92/د/105/2495
Health conditions studied
1
Description of health condition studied
Heart rate
ICD-10 code
R00
ICD-10 code description
Abnormalities of heart beat
2
Description of health condition studied
Blood pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis
Primary outcomes
1
Description
Blood pressure
Timepoint
During surgery
Method of measurement
NIBP
2
Description
Heart rate
Timepoint
During surgery
Method of measurement
ECG
Secondary outcomes
1
Description
Duration of recovery room
Timepoint
Recovery room
Method of measurement
Hour
2
Description
Degree of pain
Timepoint
Recovery room
Method of measurement
VAS
3
Description
Nasa and Vomiting
Timepoint
Recovery room
Method of measurement
Observation
4
Description
Hypotention
Timepoint
During in surgery and recovery room
Method of measurement
NIBP
5
Description
Bradicardia
Timepoint
During in surgery and recovery room
Method of measurement
ECG
Intervention groups
1
Description
Starting at the anesthesia, patients receive a loading dose of dexmedetomidine 1 micg/kg i.v. administerrd over 10 min followed by a continuous infusion of 0.7 micg/kg per h.
Category
Treatment - Drugs
2
Description
Starting at the anesthesia, patients receive a loading dose of remifentanil 1micg/kg i.v. given over 1min followed by a continuous infusion of 0.2 micg/kg/min.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Farahnaz Sadeghi
Street address
Beh-Afarin st.; Karimkhan Zand st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences;Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Firouzgar Hospital
Full name of responsible person
Farahnaz Sadeghi
Position
Resident
Other areas of specialty/work
Street address
Firouzgar Hospital
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
farahnazsadeghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Firouzgar Hospital
Full name of responsible person
Farahnaz Sadeghi
Position
Resident
Other areas of specialty/work
Street address
Firouzgar Hospital
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
farahnazsadeghi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)