Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
This study has been completed.
Sponsor:
Shanghai 9th People's Hospital
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
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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
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
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
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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 sample number is relatively small |
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
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 |