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The Realtime Detection for Individual Variation of Analgesic :A Comparison of Sufentanil vs Fentanyl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01748071
First received: December 9, 2012
Last updated: September 22, 2013
Last verified: September 2013
Results First Received: May 30, 2013  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Surgery
Individuality

  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
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
Sufentanil Group Grouped by intravenous injection of sufentanil at the time of anesthesia induction
Fentanyl Group Grouped by intravenous injection of fentanyl at the time of anesthesia induction
Saline Group Grouped by intravenous injection of saline before the time of anesthesia induction

Participant Flow:   Overall Study
    Sufentanil Group   Fentanyl Group   Saline Group
STARTED   40   40   40 
COMPLETED   38   38   40 
NOT COMPLETED   2   2   0 
Adverse Event                2                2                0 



  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
Sufentanil Group Grouped by intravenous injection of sufentanil at the time of anesthesia induction
Fentanyl Group Grouped by intravenous injection of fentanyl at the time of anesthesia induction
Saline Group Grouped by intravenous injection of saline before the time of anesthesia induction
Total Total of all reporting groups

Baseline Measures
   Sufentanil Group   Fentanyl Group   Saline Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   40   120 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   40   40   40   120 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (12)   47  (13)   49  (11)   48  (13) 
Gender 
[Units: Participants]
       
Female   40   40   40   120 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
China   40   40   40   120 


  Outcome Measures
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1.  Primary:   Mean Pressure Pain Threshold   [ Time Frame: 10 minutes after the procedure ]

2.  Primary:   Mean Value of Narco-trend Index   [ Time Frame: 10 minutes after the procedure ]

3.  Secondary:   Mean Arterial Pressure   [ Time Frame: 10 minutes after the procedure ]

4.  Secondary:   Mean Heart Rate   [ Time Frame: 10 minutes after the procedure ]

5.  Secondary:   Mean Respiratory Frequency   [ Time Frame: 10 minutes after the procedure ]


  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
Because 3 patients couldn't maintain the SPO2 at 90% and 1 patient was at deep sedation, 4 subject patients were not analysed in the final results. These patients were performed as a routine intravenous anesthetic induction.


  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: Xianwei Zhang
Organization: Huazhong University of Science&Technology
phone: 027 83662853
e-mail: ourpain@163.com



Responsible Party: Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01748071     History of Changes
Other Study ID Numbers: Individual Variation
Study First Received: December 9, 2012
Results First Received: May 30, 2013
Last Updated: September 22, 2013
Health Authority: China: Food and Drug Administration