Effect of Dexmedetomidine on Pain Due to Propofol Injection
| Tracking Information | |||||
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| First Received Date ICMJE | September 30, 2011 | ||||
| Last Updated Date | October 31, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain score after propofol injection [ Time Frame: upto 24 hours ] [ Designated as safety issue: No ] After injecting study drugs the pain score after propofol was assessed by using visual rating scale and given score according to severity of pain 0 = no pain,
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01463332 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence of Pain recall in postoperative recovery room [ Time Frame: Upto 24 hrs. ] [ Designated as safety issue: No ] All patient were observed for 2-hrs in recovery room and were asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as 0-No recall of pain 1-Recall of pain present. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Dexmedetomidine on Pain Due to Propofol Injection | ||||
| Official Title ICMJE | Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial | ||||
| Brief Summary | Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10 mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain probably results from a direct irritant effect. Several methods have been used to reduce this pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain, but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2 adrenoreceptor agonist. 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. Investigators conducted a study to determine the efficacy of dexmedetomidine in decreasing pain due to injection of propofol. |
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| Detailed Description | Propofol solution is fat emulsion consisting of soyabean oil. When used for anesthetic induction, propofol causes pain or discomfort on injection. Many factors appear to affect the incidence of pain, which includes site of injection, size of vein, speed of injection, buffering effect of blood, temperature and composition of propofol solution and concomitant use of drugs such as local anaesthetics and opiates. 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | October 2011 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01463332 | ||||
| Other Study ID Numbers ICMJE | SMC/CT/3/2011, KVGMCH/CT/2/2011 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Shivakumar M C, MD, KVG Medical College and Hospital | ||||
| Study Sponsor ICMJE | KVG Medical College and Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | KVG Medical College and Hospital | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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