Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
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| First Received Date ICMJE | October 22, 2009 | ||||||||
| Last Updated Date | February 4, 2013 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
adequate sedation via Bispectral Index Score and University of Michigan Sedation Scale [ Time Frame: during operative procedure ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01001429 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
time to achieve "street fitness" [ Time Frame: for 2 hours post-operatively in Post Anesthesia Care unit ] [ Designated as safety issue: No ] Subjects will be kept in the PACU for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge. |
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| Original Secondary Outcome Measures ICMJE |
post-operative pain score [ Time Frame: for 2 hours post-operatively in Post anesthesia Care unit ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dexmedetomidine Versus Propofol in Vitreoretinal Surgery | ||||||||
| Official Title ICMJE | Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block | ||||||||
| Brief Summary | The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose can prevent or reduce the incidence of adverse effects, while providing adequate sedation, and respiratory stability as compared to propofol. |
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| Detailed Description | Alpha2 adrenergic receptor agonist have been used increasingly as a new armamentarium to provide sedative/hypnotic, analgesic, anxiolytic and sympatholytic effects in the perioperative settings. Dexmedetomidine, a selective and specific alpha2- adrenoceptor agonist has unique properties that makes it an almost ideal sedative drug for monitored anesthesia care in procedures under local or regional block. Unlike other drugs use for sedation, dexmedetomidine induces sedation that is similar to natural sleep (readily arousable) without causing respiratory depression. It attenuates the stress-induced sympathoadrenal response seen with laryngoscopy and intubation. It has anesthetic and opioid sparing effects, hence it may be a useful adjunct to general anesthesia and monitored anesthesia care in patients susceptible to narcotic induced respiratory depression. Another unique property of dexmedetomidine is that its sedative effect is reversible with Atipamezole. A previous study wherein dexmedetomidine has been used in procedures under local and regional block had shown that it provides effective sedation and better operating condition without significant respiratory depression. As a supplement to general anesthesia, it has been shown to provide stable hemodynamics. However, it is associated with some adverse events such as hypertension, hypotension and bradycardia, these commonly occur during bolus administration of the recommended dose of 1ug/kg. Post-operatively it can cause nausea and vomiting. Vitreoretinal surgery requires either an injection of local anesthetic within the muscle cone (retrobulbar block),or into the periorbital space (peribulbar block). This can be done individually or in combination. This surgery can also be done under a safer technique of retrobulbar block that is given using a sub-tenon's approach through a snip peritomy; a blunt cannula can be used with this technique mitigating the complications of retrobulbar hemorrhage or inadvertent injection into the optic nerve sheath or perforation of the globe using a sharp needle. The anesthetic goal is to provide an immobile and uncongested operative field. Hemodynamic stability of the patient is also important since some patients that require this procedure are elderly with co-morbid conditions such as hypertension, diabetes mellitus and CAD. In our study we would like to investigate if Dexmedetomidine alone and in a reduced dose can prevent or reduce the incidence of adverse effects, provide hemodynamic and respiratory stability, provide adequate sedation with patient and surgeon satisfaction and compare it with Propofol. Objectives: Primary:
Secondary:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Ambulatory Surgery | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 78 | ||||||||
| Estimated Completion Date | February 2014 | ||||||||
| Estimated Primary Completion Date | March 2013 (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 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01001429 | ||||||||
| Other Study ID Numbers ICMJE | 0120090202 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Anesthesia, University of Medicine and Dentistry New Jersey | ||||||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||||||
| Verification Date | February 2013 | ||||||||
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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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