Effect of Dexmedetomidine on Pain Due to Propofol Injection
NCT ID: NCT01463332
Last Updated: 2011-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
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Detailed Description
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Pain on injection of propofol can be immediate or delayed. Immediate pain probably results from a direct irritant effect whereas delayed pain probably results from an indirect effect via the kinin cascade. Delayed pain has latency of between 10 and 20 s. The pain produced is usually described as tingling, cold, or numbing, at its worst, a severe burning pain proximal to the site of injection. This sensation tends to occur within 10-20 s of injection and lasts only for the duration of injection. Despite this discomfort, the incidence of phlebitis is less than 1%.
Several methods have been used to reduce this pain with limited success. Lidocaine pretreatment is commonly used to decrease propofol induced pain, but its failure rate is between 13-32%.
Dexmedetomidine is an selective alfa-2 adrenoreceptor agonist with supraspinal, spinal, and peripheral actions. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group NS
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
I.V injection of 10 ml normal saline
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
Group D25
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
I.V injection with 0.25mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Group D50
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
I.V injection of 0.50mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Interventions
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I.V injection of 10 ml normal saline
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
I.V injection with 0.25mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
I.V injection of 0.50mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both gender
* Age 18-60
* Elective surgery
Exclusion Criteria
* History of allergic reactions to anesthetic drugs,
* Atrio-ventricular conduction defects
* Cardiovascular disease and
* Pregnant
18 Years
60 Years
ALL
No
Sponsors
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KVG Medical College and Hospital
OTHER
Responsible Party
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Shivakumar M C, MD
Assistant Professor
Principal Investigators
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Shivakumar M C, MD
Role: PRINCIPAL_INVESTIGATOR
KVG Medical College and Hospital
Other Identifiers
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KVGMCH/CT/2/2011
Identifier Type: OTHER
Identifier Source: secondary_id
SMC/CT/3/2011
Identifier Type: -
Identifier Source: org_study_id