The Effect of Intrathecal Midazolam on quality and duration of Spinal Anaesthesia in TURP
Design
In this double blind clinical trail 64 patients who will be scheduled for Inguinal Herniorrhaphy under Spinal Anesthesia(SA) in Velayat & Rajaee hospital of Qazvin will be randomly divided in 2 equal 32 patient group . 500 Ml Ringer will be infused to patients. Standard monitoring will be started for patient. SA will be done in sitting position via L3-L4 space using disposable (G=26) needle. Following SA patient immediately turned to supine position
Blinding: Patient, Anesthesiologist who do spinal anesthesia, and the Anesthesiologist who evaluate study outcomes are unaware about patients grouping.
Settings and conduct
In this Double blind clinical trail 64patients who will be scheduled for Inguinal Herniorrhaphy under Spinal Anesthesia in Velayat & Rajaee hospital of Qazvin will be randomly divided in 2 equal groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA I or II; male age
30–70 y
Exclusion: drug abusers; motor sensory nerve disturbances; Diabete Mellitus; known sensitivity to
study drugs used; spinal deformity or contraindication to
SA
Intervention groups
Induction of spinal anesthesia will be done by using 10mg Bupivacaine plus2 mg Midazolam in study group, and the same value of Bupivacaine plus 0.4ml 0.9% normal saline in control group (volume of drug will be reached to 2.4 ml in both group)
Main outcome variables
time of regression of sensory block & motor block to modified bromage scale 1. cardiovascular change during of anesthesia, and complication of block
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151223025676N9
Registration date:2018-12-23, 1397/10/02
Registration timing:registered_while_recruiting
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Hamid Kayalha
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1007
Email address
hkayalha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of adding Midazolam to Bupivacaine 0.5% On duration Of Spinal Anaesthesia In Inguinal Herniorrhaphy
Public title
The Effect Of adding Midazolam to Bupivacaine 0.5% On duration Of Spinal Anaesthesia In Inguinal Herniorrhaphy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists 1,2
Exclusion criteria:
Motor / sensory nerve disturbances
Diabetes Mellitus
known sensitivity to study drugs used,
The Reluctance of patients
Any other standard contraindication to spinal anesthesia
Drug or Alcohol abusers
Age
From 30 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with WIN PEPI
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient, Anesthesiologist who do spinal anesthesia, and the Anesthesiologist who evaluate study outcomes are unaware about patients grouping .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin.
Province
Qazvin
Postal code
3419759811
Approval date
2018-02-27, 1396/12/08
Ethics committee reference number
IR.QUMS.REC.1396.486
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Time of regression of Sensory Block
Timepoint
Every 5 min in post anesthesia care unit
Method of measurement
Time need to regression of Sensory block to 2 lower dermathom level
2
Description
Time need to regression of Motor block
Timepoint
Every 5 min in post anesthesia care unit
Method of measurement
Based on Modified Bromage Scale
3
Description
First time of feeling pain
Timepoint
24 hours after surgery
Method of measurement
Score of Pain according to Visual Analog Scale
Secondary outcomes
1
Description
Cardiovascular chang
Timepoint
every 5 min
Method of measurement
Using indirect Blood Pressure measurement &Heart rate via automated devise