Comparison of hemodynamic changesbetween two methods of sedation with midazolam - fentanyl and propofol - fentanyl in patients undergoing ovarian puncture surgery
The purpose of this double-blind clinical trial study is to comparison of hemodynamic changes between sedation by midazolam_fentanyl versus propofol_fentanyl in patients who undergoing ovarian puncture procedure in Imam Khomeini hospital during 2015-2016. The inclusion criteria include: infertile women between 21 -39 years; normal blood pressure; class I and II ASA; lack of sensitivity to propofol, undergoing puncture elective surgery. Exclusion criteria include: unwillingness to participate in the study; puncture procedure took more than 10 minutes. 56 patients will be randomized into two groups in blocks of 4: Group A (28) patients (propofol-fentanyl) and B (28) patients (midazolam-fentanyl) will be considered.
Patients in group A, Will be sedate by propofol 1mg/kg, fentanyl 1 micrograms/kg and patients in group B will be sedate by midazolam 0.05mg/kg, fentanyl 1 micrograms/kg while receiving oxygen and N2O 4lit/min via bag- mask ventilation.
After securing the sedation, surgery will begin. The systolic and diastolic blood pressure, heart rate, respiratory rate and O2 saturation before induction, then 3, 5 and 10 minutes after induction will be evaluated. Then, the hemodynamics parameters will be evaluated and will be recorded when the patients are delivered to and left the recovery Ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092814802N1
Registration date:2016-05-25, 1395/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Sara Adarvishi
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1377 7966
Email address
adarvishi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changesbetween two methods of sedation with midazolam - fentanyl and propofol - fentanyl in patients undergoing ovarian puncture surgery
Public title
Changes in vital signs in two ways of anesthesia with midazolam- fentanyl and propofol- fentanyl in patients with infertility surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: infertile women between 21 -39 years; normal blood pressure; class I and II ASA; lack of sensitivity to propofol, undergoing puncture elective surgery.
Exclusion criteria: unwillingness to participate in the study; puncture procedure took more than 10 minutes.
Age
From 21 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Ethics committee of ahvaz University of Medical Sciences
Street address
Ethics Committee, vice-chancellor for research and technology, Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
ahvaz
Postal code
6135715794
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
Ajums.REC.1394.561
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N99.9
ICD-10 code description
Other disorders of the genitourinary system
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
Before induction, then 3, 5 and 10 minutes after induction
Method of measurement
Portable analog pressure gauge
2
Description
heart rate
Timepoint
Before induction, then 3, 5 and 10 minutes after induction
Method of measurement
monitoring
3
Description
respiratory rate
Timepoint
Before induction, then 3, 5 and 10 minutes after induction
Method of measurement
Observation chest in a minute
4
Description
saturation of oxygen
Timepoint
Before induction, then 3, 5 and 10 minutes after induction
Method of measurement
Pulse oximeter probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:
Patients in group A Will be sedate by propofol 1mg/kg, fentanyl 1 micrograms/kg while receiving oxygen and N2O 4lit/min via bag- mask ventilation. After securing the sedation, surgery will begin. The systolic and diastolic blood pressure, heart rate, respiratory rate and O2 saturation before induction, then 3, 5 and 10 minutes after induction will be evaluated.
Category
Treatment - Drugs
2
Description
Intervention group 2:
will be sedate by midazolam 0.05mg/kg, fentanyl 1 micrograms/kg while receiving oxygen and N2O 4lit/min via bag- mask ventilation. After securing the sedation, surgery will begin. The systolic and diastolic blood pressure, heart rate, respiratory rate and O2 saturation before induction, then 3, 5 and 10 minutes after induction will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
imam khomeini hospital of ahvaz
Full name of responsible person
saeed haji taheri
Street address
imam khomeini hospital of ahvaz, azadegan street, ahvaz, khozestan.
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, Ahvaz, Khozestan
City
ahvaz
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 and technology of Ahvaz Jundishapur 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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
sara adarvishi
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
ahvaz
Postal code
6143994353
Phone
+98 61 3377 7966
Fax
Email
adarvishi.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
saeed haji taheri
Position
resident of Anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, medicine school, Golestan road, Ahvaz, Khozestan
City
ahvaz
Postal code
Phone
+98 613777966
Fax
Email
adarvishi.s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
sara adarvishi
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
6143994353
Phone
+98 61 3222 2114
Fax
Email
adarvishi.s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)