Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety of Remifentanil Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01303627
First received: February 24, 2011
Last updated: June 15, 2012
Last verified: June 2012
Results First Received: January 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Urinary Tract Problem
Intervention: Drug: remifentanil

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ultiva,Remifentanil,Opioid,Analgesic Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
Control Control:Remifentanil stopped at the end of the surgery

Participant Flow:   Overall Study
    Ultiva,Remifentanil,Opioid,Analgesic     Control  
STARTED     21     21  
COMPLETED     21     20 [1]
NOT COMPLETED     0     1  
the failure while performing URS                 0                 1  
[1] One patient excluded from the study because of the failure while performing uretero-renoscopy



  Baseline Characteristics
  Hide Baseline Characteristics

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
Ultiva,Remifentanil,Opioid,Analgesic Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
Control Control:Remifentanil stopped at the end of the surgery
Total Total of all reporting groups

Baseline Measures
    Ultiva,Remifentanil,Opioid,Analgesic     Control     Total  
Number of Participants  
[units: participants]
  21     20     41  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     20     41  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41  ± 13     38  ± 12     39  ± 12  
Gender  
[units: participants]
     
Female     2     6     8  
Male     19     14     33  
Region of Enrollment  
[units: participants]
     
Turkey     21     20     41  



  Outcome Measures

1.  Primary:   Smooth cLMA Removal Condition (Score 1)   [ Time Frame: At the end of the surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The limitation of our study is age and ASA status of the included patients’. The relatively older or ASA status III,IV population may interfere the effect-site concentration TCI of remifentanil


  More Information
  Hide More Information

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: Derya Özkan MD
Organization: Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology
phone: 0903125962553
e-mail: derya_z@yahoo.com


Publications of Results:

Responsible Party: derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01303627     History of Changes
Other Study ID Numbers: DiskapiTRH
Study First Received: February 24, 2011
Results First Received: January 30, 2012
Last Updated: June 15, 2012
Health Authority: Turkey: Ethics Committee