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The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.
Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Active Comparator | a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h |
|
| remifentanil | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine group | Drug | 1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopy Scores | 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 | during the procedure of fibreoptic and tracheal intubation |
| Intubation Score | 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 | during the inserting of the tracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Reaction to Procedure | Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level. Clinical score Level of sedation
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang, MD, PHD | Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai JiaoTong University, School of Medicine | Shanghai | Shanghai Municipality | 200011 | China | ||
| Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine |
One patient declined consent and one operation was cancelled.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Remifentanil Target Controlled Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Patient's Reaction to Procedure | Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level. Clinical score Level of sedation
| Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study. | Posted | Median | Inter-Quartile Range | units on a scale | the duration of intubation, an expected average of 10 minutes |
|
during the endoscopy and intubation period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Non-systematic Assessment |
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The sample number is relatively small
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jiang Hong | Department of Anaesthetics, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | 86-21-13512122883 | hr310@vip.sina.com.cn |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| remifentanil group | Drug | target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration) |
|
|
| the duration of intubation, an expected average of 10 minutes |
| Post Operative Visit | 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. | 24 hours |
| Mean Arterial Blood Pressure | MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point |
| Heart Rate | Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point |
| Peripheral Oxygen Saturation(SPO2) | Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point |
| Cardiac Rhythm | 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. | 15 minutes before intubation and duration of intubation |
| Post Intubation Score | Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome. Post-intubation score 1 2 3
| immediately after the intubation |
| Shanghai |
| Shanghai Municipality |
| 200011 |
| China |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
| OG001 | Dexmedetomidine Continuously 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. |
|
|
| Secondary | Post Operative Visit | 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. | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Mean Arterial Blood Pressure | MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | Posted | Mean | Standard Deviation | mmHg | 15 minutes before intubation, endoscopy point, intubation point |
|
|
|
| Secondary | Heart Rate | Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | Posted | Mean | Standard Deviation | beats per minute | 15 minutes before intubation, endoscopy point, intubation point |
|
|
|
| Secondary | Peripheral Oxygen Saturation(SPO2) | Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | Posted | Mean | Standard Deviation | percentage oxygen saturation | 15 minutes before intubation, endoscopy point, intubation point |
|
|
|
| Secondary | Cardiac Rhythm | 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. | Posted | Number | participants | 15 minutes before intubation and duration of intubation |
|
|
|
| Primary | Endoscopy Scores | 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 | Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study. | Posted | Median | Inter-Quartile Range | units on a scale | during the procedure of fibreoptic and tracheal intubation |
|
|
|
| Primary | Intubation Score | 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 | Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study. | Posted | Median | Inter-Quartile Range | units on a scale | during the inserting of the tracheal tube |
|
|
|
| Secondary | Post Intubation Score | Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome. Post-intubation score 1 2 3
| Posted | Median | Inter-Quartile Range | units on a scale | immediately after the intubation |
|
|
|
| 3 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 2 | 20 | 0 | 20 |
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| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| MAP at endoscopy point |
|
| Heart rate at intubation point |
|
| at intubation point |
|