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Completed

NCT Number: NCT01001429

Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UMDNJ-University Hospital, Newark, New Jersey, United States

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About this study

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 Coronary Artery Disease (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:

  • Adequate sedation
  • Hemodynamic and respiratory stability intraoperatively

Secondary:

  • surgeon satisfaction
  • Time to achieved " street fitness " status
  • subject satisfaction
  • Hemodynamic stability in PACU

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists rating of I-III
  • good renal and liver function

Exclusion criteria

  • renal and hepatic insufficiency
  • uncontrolled diabetes
  • uncontrolled hypertension
  • severe cardiac disease Class III or IV
  • heart blocks
  • chronic use of sedatives, narcotics, alcohol or illicit drugs
  • allergy to either propofol or dexmedetomidine
  • pregnancy or inability to tolerate technique of the study drugs

Treatment and study plan

Dexmedetomidine infusion

Drug

bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug

Other names: Precedex infusion

Propofol

Drug

propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min

Other names: Diprivan

Primary outcomes

  1. Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)

    Time frame: Intraoperative up to 120 min

    Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.

  2. Intraoperative Hemodynamic Stability

    Time frame: Intraoperative up to 120 min

    systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm

  3. Intraoperative Respiratory Stability

    Time frame: Intraoperative up to 120 min

    respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm

  4. Intraoperative Heart Rate Stability

    Time frame: Intraoperative up to 120 min

    Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

Secondary outcomes

  1. Time to Achieve "Street Fitness"

    Time frame: for 2 hours post-operatively in Post Anesthesia Care unit

    Subjects will be kept in the Post Anesthesia Care Unit (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.

  2. Surgeon Satisfaction for Adequate Sedation

    Time frame: at 10 minutes into the procedure

    1=very poor, 2=poor,3=fair, 4=good, 5=excellent

  3. Surgeon Satisfaction for Adequate Sedation at Completion of Procedure

    Time frame: immediately following the completion of the procedure up to one hour

    surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent

  4. Patient Satisfaction

    Time frame: measured prior to discharge up to 2 hours

    1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent

  5. Post Operative Hemodynamic Stability

    Time frame: 2 hours in PACU

    blood pressure documented at 30 minute intervals in PACU up to 120 min

  6. Hemodynamic Stability Post Operatively in PACU

    Time frame: PACU to 2 hours post op

    heart rate recorded at 30 min intervals in PACU up to 120 min

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2009
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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