Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT01463332
Status:
UNKNOWN
Last Update Posted:
2011-11-01
First Post:
2011-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Pain Due to Propofol Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-31', 'studyFirstSubmitDate': '2011-09-30', 'studyFirstSubmitQcDate': '2011-10-31', 'lastUpdatePostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score after propofol injection', 'timeFrame': 'upto 24 hours', 'description': '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,\n\n1. = mild pain or soreness,\n2. = moderate pain and\n3. = severe pain associated with facial grimacing, arm withdrawal, movement or both.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Pain recall in postoperative recovery room', 'timeFrame': 'Upto 24 hrs.', 'description': '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\n\n0-No recall of pain\n\n1-Recall of pain present.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Propofol', 'Pain', 'Dexmedetomidine'], 'conditions': ['Pain', 'Intravenous Propofol Injection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPain 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%.\n\nSeveral 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%.\n\nDexmedetomidine 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I \\& II\n* Both gender\n* Age 18-60\n* Elective surgery\n\nExclusion Criteria:\n\n* Patients taking sedatives or analgesics in the past 24 hours\n* History of allergic reactions to anesthetic drugs,\n* Atrio-ventricular conduction defects\n* Cardiovascular disease and\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01463332', 'briefTitle': 'Effect of Dexmedetomidine on Pain Due to Propofol Injection', 'organization': {'class': 'OTHER', 'fullName': 'KVG Medical College and Hospital'}, 'officialTitle': 'Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SMC/CT/3/2011'}, 'secondaryIdInfos': [{'id': 'KVGMCH/CT/2/2011', 'type': 'OTHER', 'domain': 'KVG Medical college and hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group NS', 'description': '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.', 'interventionNames': ['Drug: I.V injection of 10 ml normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D25', 'description': '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.', 'interventionNames': ['Drug: I.V injection with 0.25mic/kg of dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D50', 'description': '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.', 'interventionNames': ['Drug: I.V injection of 0.50mic/kg of dexmedetomidine']}], 'interventions': [{'name': 'I.V injection of 10 ml normal saline', 'type': 'DRUG', 'otherNames': ['Group NS'], 'description': '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.', 'armGroupLabels': ['Group NS']}, {'name': 'I.V injection with 0.25mic/kg of dexmedetomidine', 'type': 'DRUG', 'otherNames': ['dexmedetomidine'], 'description': '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.', 'armGroupLabels': ['Group D25']}, {'name': 'I.V injection of 0.50mic/kg of dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': '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.', 'armGroupLabels': ['Group D50']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shivakumar M C, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KVG Medical College and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KVG Medical College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shivakumar M C, MD', 'investigatorAffiliation': 'KVG Medical College and Hospital'}}}}