Comparsion of Midazolam and Dexmedetomidine for pain relief and decreasing fallopian tubes spasm during and after hysterosalpingography in infertile women
The aim of this study is comparison of Midazolam and Dexmedetomidine for pain relief and decreasing fallopian tubes spasm during and after hysterosalpingography in infertile women. This study is a double blind clinical trial. 102 women will be divided into two groups randomly (randomization will be done by random numbers table). We will inject 0.4 milligram per kilogram Midazolam, 3-4 minutes before surgery and we will continue infusion of normal slain 0.5 microgram per kilogram in first group. In second group we will inject 1 microgram in kilogram Dexmedetomidin and we will continue treatment with the infusion of 0.5 microgram per kilogram Dexmedetomidine. We will start the process when sedation is 2 and 3in Ramsy scales. We will determine pain score using visual analog scale. We will record presence or absence of spasm of fallopian tubes during hysterosalpingography. Inclusion criteria: being female; infertility; being at the age of 20 to 45 years. Exclusion criteria: Contraindications for the use of Dexmethomidine and Midazolam; uterine malignancy; vaginal bleeding; history of cervical surgery; pelvic inflammation; use of any kind of housing before hysterosalpingography; obstruction of fallopian tubes greater than 45 minutes; Unstable hydrodynamic symptoms during hysterosalpingography; Vaginal delivery; Secondary infertility. Primary outcomes: pain; spasm in fallopian tube.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081520258N57
Registration date:2017-10-12, 1396/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-05-15, 1396/02/25
Expected recruitment end date
2019-05-15, 1398/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of Midazolam and Dexmedetomidine for pain relief and decreasing fallopian tubes spasm during and after hysterosalpingography in infertile women
Public title
Pain relief and decreasing fallopian tubes spasm during and after hysterosalpingography in infertile women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: infertility; 20 to 45 years
Exclusion criteria: Contraindications for the use of Dexmethomidine and Midazolam; uterine malignancy; vaginal bleeding; history of cervical surgery; pelvic inflammation; use of any kind of pain reliever before hysterosalpingography; fallopian tubes obstruction.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomize by random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Intervention group 2: We will inject 1 micro gram in kilogram Dexmedetomidin and we will continue drug therapy by 0/5 micro gram in kilogram Dexmedetomidine through infusion.
Category
Treatment - Drugs
2
Description
Intervention group 1: We will inject 0/4 milligram in kilogram Midazolam, single dose, 3-4 minute before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private radiology clinic
Full name of responsible person
Dr Fatemeh Safi
Street address
Shahid Rajaee ,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences