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Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001429
First Posted: October 26, 2009
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
Results First Submitted: February 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Retinal Detachment
Interventions: Drug: Dexmedetomidine infusion
Drug: propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited the morning of surgery in the Same Day Surgery Suite

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject withdrew consent prior to group assignment. One subject surgery was cancelled

Reporting Groups
  Description
Propofol

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

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

Dexmedetomidine Infusion

Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.

Dexmedetomidine infusion: 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


Participant Flow:   Overall Study
    Propofol   Dexmedetomidine Infusion
STARTED   39   38 
COMPLETED   39   37 
NOT COMPLETED   0   1 
surgery cancelled                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Propofol

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

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

Dexmedetomidine Infusion

Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.

Dexmedetomidine infusion: 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

Total Total of all reporting groups

Baseline Measures
   Propofol   Dexmedetomidine Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   37   76 
Age 
[Units: Years]
Mean (Inter-Quartile Range)
 40 
 (40 to 60) 
 52 
 (42.8 to 61.2) 
 46 
 (40 to 61.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  28.2%      12  32.4%      23  30.3% 
Male      28  71.8%      25  67.6%      53  69.7% 
total participants 
[Units: Participants]
 39   37   76 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)   [ Time Frame: Intraoperative up to 120 min ]

2.  Primary:   Intraoperative Hemodynamic Stability   [ Time Frame: Intraoperative up to 120 min ]

3.  Primary:   Intraoperative Respiratory Stability   [ Time Frame: Intraoperative up to 120 min ]

4.  Primary:   Intraoperative Heart Rate Stability   [ Time Frame: Intraoperative up to 120 min ]

5.  Secondary:   Time to Achieve "Street Fitness"   [ Time Frame: for 2 hours post-operatively in Post Anesthesia Care unit ]

6.  Secondary:   Surgeon Satisfaction for Adequate Sedation   [ Time Frame: at 10 minutes into the procedure ]

7.  Secondary:   Surgeon Satisfaction for Adequate Sedation at Completion of Procedure   [ Time Frame: immediately following the completion of the procedure up to one hour ]

8.  Secondary:   Patient Satisfaction   [ Time Frame: measured prior to discharge up to 2 hours ]

9.  Secondary:   Post Operative Hemodynamic Stability   [ Time Frame: 2 hours in PACU ]

10.  Secondary:   Hemodynamic Stability Post Operatively in PACU   [ Time Frame: PACU to 2 hours post op ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Termination of study due to difficulty recruiting subjects who fit the study criteria.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anuradha Patel, MD
Organization: Rutgers New Jersey Medical School
phone: 973 972-1886
e-mail: patelan@njms.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01001429     History of Changes
Other Study ID Numbers: 0120090202
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: February 11, 2016
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017