Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rong Hu, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier:
NCT01474213
First received: October 31, 2011
Last updated: October 22, 2012
Last verified: October 2012
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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


No publications provided


Responsible Party: Rong Hu, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier: NCT01474213     History of Changes
Other Study ID Numbers: JYMZK-002
Study First Received: October 31, 2011
Results First Received: June 6, 2012
Last Updated: October 22, 2012
Health Authority: China: Food and Drug Administration