Comparative investigation of Dexmedetomidine Hemodynamic infusion by intermittent injection of sufentanil-midazolam on sedation of patients during cataract surgery
This study will be done to compare Dexmedetomidine Hemodynamic infusion and intermittent injection of sufentanil-midazolam on sedation of patients during cataract surgery. This study is a double blind clinical trial. The study population will include all patients scheduled for cataract surgery referred to Imam Khomeini hospital, Kermanshah city. 60 eligible patients will be selected by available sampling method and randomly divided into two D and S groups. In the experimental group D, from 10 min before the beginning of operation Dexmedetomidine at the dose of 0 .5μg / kg will be infused by anesthesiology assistant and in the experimental group S, sufentanil 0.1 μg / kg and midazolam 0.2 μg / kg will be injected 5 minutes before the start of operation and Dexmedetomidine infusion at a dose of 0/02 μg / kg / h will be continued. MAP- HR- SP2 will be recorded before infusion and every 5 min after infusion by anesthesia assistant and the level of sedation and relief based on Ramsey standards will be measured and compared in both groups. Inclusion criteria: Age between 30 -70 years; ASA class I, II, III. Exclusion criteria: Pregnant women; Patients with lung disease; Kidney disease; Liver disease; Blood pressure greater than 180; Blood pressure less than 90;Heart rate greater than 120;Heart rate less than 60; History of Alcohol or drugs use, chronic use of analgesics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061014333N77
Registration date:2017-07-18, 1396/04/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-06-20, 1396/03/30
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation of Dexmedetomidine Hemodynamic infusion by intermittent injection of sufentanil-midazolam on sedation of patients during cataract surgery
Public title
Investigation of Dexmedetomidine Hemodynamic infusion on sedation during cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30 -70 years; ASA class I, II, III. Exclusion criteria: Pregnant women; Patients with lung disease; Kidney disease; Liver disease; Blood pressure greater than 180; Blood pressure less than 90;Heart rate greater than 120;Heart rate less than 60; History of Alcohol or drugs use, chronic use of analgesics
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Based on random numbers table.In this way, a code is assigned to the sample.The researcher to select a sample from the table,start by chance from a point of table to the row or column.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
kums.rec.1396.35
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Senile Cataract
Primary outcomes
1
Description
Sedation
Timepoint
After the end of the study
Method of measurement
Based on Ramsey Hunt standard
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group D, 0.5μg /kg Dexmedetomidine will be injected by anesthesiology assistant from 10 min before the beginning of operation.
Category
Treatment - Drugs
2
Description
In the experimental group S, 0.1μg /kg Sufentanil and 0.2 μg/kg Midazolam will be injected by anesthesiology assistant from 10 min before the beginning of operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Azam Tavakolifar
Street address
Imam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, ShahidBeheshti Boulevard
City
Kermanshah
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, Kermanshah 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
kermanshah University of Medical Sciences
Full name of responsible person
Azam Tavakolifar
Position
Residents of anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
Dr_Tavakoli_A@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Naser Yeganeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
nyeganeh@Kumsoak.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azam Tavakolifar
Position
Residents of anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
Dr_Tavakoli_A@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)