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Trial: NCT01001429 [RDF]

Label NCT01001429
Slug nct01001429
Trialid NCT01001429
Lookup name NCT01001429
Lastchanged date September 3, 2014
Firstreceived results date
Firstreceived date October 22, 2009
Id info nct id NCT01001429
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 78
Number of arms 2
Is section 801
Is fda regulated No
Brief title Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
Official title Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block
Study type Interventional
Id info nct alias
Completion date November 2013
Verification date August 2014
Why stopped
Id info org study id 0120090202
Required header url
Study design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Source Rutgers, The State University of New Jersey
Primary completion date March 2013
Brief summary
Number of groups
Required header download date processed this data on September 07, 2016
Phase Phase 4
Start date October 2009
Has expanded access No
Biospec descr
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: 1. Adequate sedation 2. Hemodynamic and respiratory stability Secondary: 1. surgeon and subject satisfaction 2. Incidence of nausea and vomiting 3. Time to achieved " street fitness " status 4. Post op hemodynamic stability
Condition browse None
Intervention browse 49557506e3d12d589608ce666995c62f
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 4f0b790e217250820903f60f85131b21
Oversight info United States: Institutional Review Board (Oversight_info)
Eligibility 33697f6820dccd1b47ebbfff33bfccdc
Keywords sedation for vitreoretinal surgery
Conditions Retinal Surgery
Locations 3ad6bc2f3588e664b180778d385d1939, d88df4d5df44bb9687ea0a1947a5bae3
Links None
Results references None
Arm groups dexmedetomidine infusion (Arm Group), Propofol (Arm Group)
Location countries United States
Interventions Dexmedetomidine infusion (Intervention), propofol (Intervention)
Secondary outcomes 1bfeb3fd3566b8d9d29f5e91e3839bb1
References None
Primary outcomes fd0039fdb0c7b484af20304722d6ec72
Removed countries None
Overall officials 6f962624bd7df0c81cbb52da93f5361b