The current protocol was aimed to compare analgesic effect of adding Midazolam and Fentanyl to Intrathecal Bupivacaine 0.05% in patients with orthopedic surgery of lower limbs. Patients needed anesthesia divided into three groups including Midazolam (M), Fentanyl (F), and Normal saline (N). Seventy five patients conducted in this survey. This study was double blind that anesthesiologist who was unaware of the contents of the syringe. Also, the specialist assessing pain was not aware of patients assigned to groups. Patients were allocated in to three groups using block allocation method. All patients were provided by Normal Saline prior to induction and venipuncture was also done from upper limb distal using vein catheter no 18 for all groups. Groups M, F, and N, received respectively 0.5 mg Midazolam, 25 µg Fentanyl, and 0.5 ml Normal Saline. Inclusion criteria were as follow: 1) people aged 18-65 years that categorized into class 1 and 2 based on America Society of Anesthesiologists (ASA. Exclusion criteria were considered as: 1): patients with substance abuse, patients with symptoms of neuropathy, and lack of appropriate sensory level after performing the spinal anesthesia. To measure pain, Verbal analogue Scale was used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061810340N9
Registration date:2016-09-25, 1395/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Science
Expected recruitment start date
2015-10-17, 1394/07/25
Expected recruitment end date
2016-05-22, 1395/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic Effect of Adding Midazolam and Fentanyl to Intrathecal Bupivacaine 0.05% in Patients with Orthopedic Surgery of Lower Limbs
Public title
Analgesic Effect of Adding Midazolam and Fentanyl to Intrathecal Bupivacaine 0.05%
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: people aged 18-65 years that categorized into class 1 and 2 based on America Society of Anesthesiologists (ASA); Exclusion criteria : rejection of patients with substance abuse, patients with symptoms of neuropathy, and lack of appropriate sensory level after performing the spinal anesthesia.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Golestan
Approval date
2015-10-16, 1394/07/24
Ethics committee reference number
IR.Goums.REC.1395.105
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
Duration of analgesia
Timepoint
After intervention
Method of measurement
Duration of analgesia
Secondary outcomes
1
Description
Hemodynamic Change
Timepoint
Before Intervention, 30 ,60 and 90 minutes after intervention
Method of measurement
Sphygmomanometer, Pols oximeter
2
Description
Chills
Timepoint
After intervention
Method of measurement
Observation
3
Description
Nausea
Timepoint
After intervention
Method of measurement
Observation
4
Description
Vomiting
Timepoint
After intervention
Method of measurement
Observation
Intervention groups
1
Description
15 mg of bupivacaine 0.5% (3 cc) with 0.5 mg of midazolam
Category
Placebo
2
Description
15 mg of bupivacaine 0.5% (3 cc) with fentanyl 25 microgram (µg)
Category
Placebo
3
Description
15 milligram (mg) of bupivacaine 0.5% (equivalent to 3 cc) with 0.5 milliliter (ml) of normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Hospital
Full name of responsible person
Payam Sorodi
Street address
5 Azar Hospital, 5 Azar Street, Gorgan City, Golestan Province
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Homeira Kodam
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science
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
Golestan University of Medical Science
Full name of responsible person
Homeira Khodam
Position
Research and Technolgy Managment
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
homeira_khoddam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Payam Sorodi
Position
Anesthesia Specialist
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
payam202@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Mohamma Aryaie
Position
MSc in Epidemiology
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
Aryaiem2009@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)