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Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474213
First Posted: November 18, 2011
Last Update Posted: November 21, 2012
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):
Rong Hu, Shanghai 9th People's Hospital
Results First Submitted: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Intubation; Difficult
Interventions: Drug: dexmedetomidine group
Drug: remifentanil group

  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
Forty two adult patients, American Society of Anesthesiologist (ASA) score of I-III, were recruited for an elective awake fibreoptic nasotracheal intubation due to the diagnosis of maxillofacial cancer or fracture with limited mouth opening

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient declined consent and one operation was cancelled.

Reporting Groups
  Description
Dexmedetomidine Infusion for Sedation Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
Remifentanil Target Controlled Infusion Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.

Participant Flow:   Overall Study
    Dexmedetomidine Infusion for Sedation   Remifentanil Target Controlled Infusion
STARTED   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   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
Dexmedetomidine Infusion for Sedation Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
Remifentanil Target Controlled Infusion Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
Total Total of all reporting groups

Baseline Measures
   Dexmedetomidine Infusion for Sedation   Remifentanil Target Controlled Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (15.2)   37.8  (14.9)   38.6  (14.8) 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   9   10   19 
Region of Enrollment 
[Units: Participants]
     
China   20   20   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Endoscopy Scores   [ Time Frame: during the procedure of fibreoptic and tracheal intubation ]

2.  Primary:   Intubation Score   [ Time Frame: during the inserting of the tracheal tube ]

3.  Secondary:   Patient's Reaction to Procedure   [ Time Frame: the duration of intubation, an expected average of 10 minutes ]

4.  Secondary:   Post Operative Visit   [ Time Frame: 24 hours ]

5.  Secondary:   Mean Arterial Blood Pressure   [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]

6.  Secondary:   Heart Rate   [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]

7.  Secondary:   Peripheral Oxygen Saturation(SPO2)   [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]

8.  Secondary:   Cardiac Rhythm   [ Time Frame: 15 minutes before intubation and duration of intubation ]

9.  Secondary:   Post Intubation Score   [ Time Frame: immediately after the intubation ]


  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
The sample number is relatively small


  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: Dr. Jiang Hong
Organization: Department of Anaesthetics, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
phone: 86-21-13512122883
e-mail: hr310@vip.sina.com.cn



Responsible Party: Rong Hu, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier: NCT01474213     History of Changes
Other Study ID Numbers: JYMZK-002
First Submitted: October 31, 2011
First Posted: November 18, 2011
Results First Submitted: June 6, 2012
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012