Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
|ClinicalTrials.gov Identifier: NCT01474213|
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Intubation; Difficult||Drug: dexmedetomidine group Drug: remifentanil group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: dexmedetomidine
a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h
Drug: dexmedetomidine group
1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine
Other Name: Dexmedetomidine Hydrochloride Injection
Active Comparator: remifentanil
The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived.
Drug: remifentanil group
target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
Other Name: Remifentanil
- Endoscopy Scores [ Time Frame: during the procedure of fibreoptic and tracheal intubation ]
Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.
Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing
- Intubation Score [ Time Frame: during the inserting of the tracheal tube ]graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing
- Patient's Reaction to Procedure [ Time Frame: the duration of intubation, an expected average of 10 minutes ]
Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.
Clinical score Level of sedation
- Patient is anxious and agitated or restless, or both
- Patient is cooperative, oriented and tranquil
- Patient responds to commands only
- Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus
- Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
- Patient exhibits no response to stimuli
- Post Operative Visit [ Time Frame: 24 hours ]visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.
- Mean Arterial Blood Pressure [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
- Heart Rate [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
- Peripheral Oxygen Saturation(SPO2) [ Time Frame: 15 minutes before intubation, endoscopy point, intubation point ]Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
- Cardiac Rhythm [ Time Frame: 15 minutes before intubation and duration of intubation ]Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.
- Post Intubation Score [ Time Frame: immediately after the intubation ]
Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.
Post-intubation score 1 2 3
- Cooperative, obeying commands
- Uncomfortable, GA imminent
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474213
|Shanghai JiaoTong University, School of Medicine|
|Shanghai, Shanghai, China, 200011|
|Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine|
|Shanghai, Shanghai, China, 200011|
|Study Chair:||Hong Jiang, MD, PHD||Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine|