Protocol summary

Study aim
Comparison of intrathecal injections of Meperidine, Teramadol, Magnesium sulfate and Dexmedetomidine in prevention of shivering and postoperative complications of femoral fracture repair under spinal anesthesia
Design
The study of the two-course clinical trial of 132 patients was randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidates for femoral fracture repair under spinal anesthesia in Valiasr Hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age18 to 75 years old; both sexes; ASA Class 1 and 2; femoral fracture repair under spinal anesthesia; no history of drug addiction; no history of seasonal allergies as well as allergies to any of the drugs used in this study; no history of neuromuscular diseases, Raynaud's disease, cardiomyopathy and coagulation disease. Exclusion criteria: failure in anesthesia and other methods; dissatisfaction with continuing to participate in the project.
Intervention groups
Dexmedetomidine group: They receive 5 micrograms of dexmedetomidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Magnesium sulfate group: They receive 25 mg of magnesium sulfate along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Meperdin group: They receive 0.2 mg / kg of meperidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Tramadol group: They receive 10 mg of tramadol (0.2 ml of tramadol hydrochloride 50 mg / ml) along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml).
Main outcome variables
Shivering intensity; sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N153
Registration date: 2021-03-09, 1399/12/19
Registration timing: prospective

Last update: 2021-03-09, 1399/12/19
Update count: 0
Registration date
2021-03-09, 1399/12/19
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
Expected recruitment start date
2021-03-15, 1399/12/25
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrathecal injections of Meperidine, Teramadol, Magnesium sulfate and Dexmedetomidine in prevention of shivering and postoperative complications of femoral fracture repair under spinal anesthesia
Public title
Comparison of intrathecal injections of Meperidine, Teramadol, Magnesium sulfate and Dexmedetomidine in prevention of shivering and postoperative complications of femoral fracture repair under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 to 75 years old Both sexes ASA Class 1 and 2 Femoral fracture repair under spinal anesthesia No history of drug addiction No history of seasonal allergies as well as allergies to any of the drugs used in this study Absence of neuromuscular diseases Absence of Raynaud's disease Absence of cardiomyopathy Absence of coagulation disease
Exclusion criteria:
Failure in anesthesia and other methods Dissatisfaction with continuing to participate in the project
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 4 groups A and B and C and D. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre, Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.ARAKMU.REC.1399.297

Health conditions studied

1

Description of health condition studied
Femoral fracture repair under spinal anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Shivering intensity
Timepoint
In recovery and every 15 minutes to 2 hours and then every 2 hours to 12 hours
Method of measurement
Fourth criterion (0-3): 0 means no shivering, 1 means mild fasciculation of the face and neck, 2 means visible tremor in more than one muscle, and 3 means intense muscle activity throughout the body.

2

Description
Sedation
Timepoint
During the operation and up to 12 hours after the operation
Method of measurement
Ramsay Sedation Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They receive 5 micrograms of dexmedetomidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Dexmedetomidine Elixir Pharmaceutical Company - Iran)
Category
Treatment - Drugs

2

Description
Intervention group: They receive 25 mg of magnesium sulfate along with 5.12 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Magnesium sulfate 10% Pasteur Institute Pharmaceutical Company - Iran)
Category
Treatment - Drugs

3

Description
Intervention group: They receive 0.2 mg / kg of meperidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Mepridine Gerot Pharmaceutical Company Vienna - Austria (Order of Darupakhsh Company)
Category
Treatment - Drugs

4

Description
Intervention group: They receive 10 mg of tramadol (0.2 ml of tramadol hydrochloride 50 mg / ml) along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Travadol Caspian Tamin Rasht Pharmaceutical Company - Iran)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeel Moshiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoureh Kokhaee
Position
medicine student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Complex Payambar azam, Basij squre, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
kokhaee@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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