Comparison of different intrathecal doses of Dexmedetomidine in terms of hemodynamic parameters and block quality after spinal anesthesia with Ropivacaine in lower limb orthopedic surgery
The purpose of this study is to compare different intrathecal doses of Dexmedetomidine in terms of hemodynamic parameters and block quality after spinal anesthesia with Ropivacaine in lower limb orthopedic surgery. Design and setting:blocked randomized, double-blind, placebo-controlled trial, single-center, clinical trial phase 2, 81 samples.Inclusion criteria:Candidate for lower limb orthopedic surgery under spinal anesthesia; Age between 18 to 60 years old; ASA class I and II. Exclusion criteria: Use of beta blockers, alpha-2 agonist and calcium channel blochers; Cardiovascular disease; Pregnancy; Coagulopathy; Local infection in the patient's caudal region; Allergy to dexmedetomidine or ropivacaine; History of psychiatric disorders; central or peripheral neuropathy.Interventions: The first group will receive 15 mg ropivacaine and 5 μg dexmedetomidine at a volume of 2 ml intrathecally. The second group will receive 15 mg ropivacaine and 10 μg dexmedetomidine at a volume of 2 ml intrathecally and the third group will receive 15 mg ropivacaine and distilled water at a volume of 2 ml intrathecally. primary outcome: mean arterial pressure; heart rate and pain severity at 1, 2, 4, 6 and 12 hours after end of operation and admission to recovery room.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070614056N12
Registration date:2017-07-29, 1396/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-29, 1396/05/07
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different intrathecal doses of Dexmedetomidine in terms of hemodynamic parameters and block quality after spinal anesthesia with Ropivacaine in lower limb orthopedic surgery
Public title
Comparison of different doses of dexmedetomidine in lower limb orthopedic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Candidate for lower limb orthopedic surgery under spinal anesthesia; Age between 18 to 60 years old; ASA class I and II. Exclusion criteria: Use of beta blockers, alpha-2 agonist and calcium channel blochers; Cardiovascular disease; Pregnancy; Coagulopathy; Local infection in the patient's caudal region; Allergy to dexmedetomidine or ropivacaine; History of psychiatric disorders; central or peripheral neuropathy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
81
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
Ethical Committee of Arak University of Medical Sciences
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.37
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
R52.0
ICD-10 code description
acute pain
Primary outcomes
1
Description
Postoperative pain
Timepoint
at 1, 2, 4, 6 and 12 hours after admission to recovery
Method of measurement
Visual analogue scale
2
Description
Mean arterial pressure
Timepoint
Every 15 min until the end of surgery
Method of measurement
sphygmomanometer
3
Description
Heart rate
Timepoint
Every 15 min until the end of surgery
Method of measurement
Cardiac monitoring
Secondary outcomes
empty
Intervention groups
1
Description
The first group will receive 15 mg ropivacaine and 5 μg dexmedetomidine at a volume of 2 ml intrathecally.
Category
Treatment - Drugs
2
Description
The second group will receive 15 mg ropivacaine and 10 μg dexmedetomidine at a volume of 2 ml intrathecally.
Category
Treatment - Drugs
3
Description
The third or control group will receive 15 mg ropivacaine and distilled water at a volume of 2 ml intrathecally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital
Full name of responsible person
Dr Hesameddin Modir
Street address
Vali-Asr Hospital, Pirouzi Ave
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Dr ali arash anoushirvani
Street address
Arak University Of Medical Science, Basij Square
City
Arak
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,Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Postal code
Phone
+98 86 3313 9793
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Postal code
Phone
+98 863417363
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Postal code
Phone
+98 863417363
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)