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A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01269918
First received: December 22, 2010
Last updated: October 26, 2016
Last verified: October 2016
Results First Received: June 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Adult Intracranial Tumor
Adult Solid Tumor
Interventions: Drug: Remifentanil
Drug: Dexmedetomidine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Remifentanil

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Dexmedetomidine

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.


Participant Flow:   Overall Study
    Remifentanil   Dexmedetomidine
STARTED   71   71 
COMPLETED   71   68 
NOT COMPLETED   0   3 
Did not receive study drug                0                3 



  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.
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Reporting Groups
  Description
Remifentanil

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Dexmedetomidine

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Total Total of all reporting groups

Baseline Measures
   Remifentanil   Dexmedetomidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   68   139 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (14)   56  (14)   56  (14) 
Gender 
[Units: Participants]
Count of Participants
     
Female      37  52.1%      33  48.5%      70  50.4% 
Male      34  47.9%      35  51.5%      69  49.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hemodynamics   [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]

2.  Primary:   Postoperative Pain   [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]

3.  Primary:   Total Opioid Consumption   [ Time Frame: Initial 90 minutes of recover after surgery ]

4.  Secondary:   Heart Rate   [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]

5.  Secondary:   Modified Short Orientation Memory Concentration Test (SOMCT)   [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]

6.  Secondary:   Aldrete Score   [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]

7.  Secondary:   Nursing Workload Comparison   [ Time Frame: 90 minutes after extubation ]

8.  Secondary:   Drug Stop Time to Open Eyes   [ Time Frame: Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes. ]

9.  Secondary:   Drug Stop Time to Recall   [ Time Frame: Time between extubation until patients could say their names. ]

10.  Secondary:   Drug Stop Time to Fitness to Discharge   [ Time Frame: Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes. ]

11.  Secondary:   End Case to Post Anesthesia Care Unit (PACU) Discharge   [ Time Frame: End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes. ]

12.  Secondary:   Postoperative Nausea   [ Time Frame: Whether patients had nausea or not, from anesthesia stop time until hospital discharge. ]

13.  Secondary:   Postoperative Vomitting   [ Time Frame: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge. ]

14.  Secondary:   Postoperative Shivering   [ Time Frame: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge. ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel Sessler, MD
Organization: Cleveland Clinic
phone: 216-445-6500
e-mail: sesslerd@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01269918     History of Changes
Other Study ID Numbers: 10-1056
Study First Received: December 22, 2010
Results First Received: June 6, 2016
Last Updated: October 26, 2016