Intubation; Difficult
Conditions
Keywords
dexmedetomidine, remifentanil, awake nasotracheal fibreoptic intubation, oral maxillofacial surgery, difficult airway, adult
Brief summary
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.
Detailed description
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.
Interventions
DRUGdexmedetomidine group
1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine
target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery
Exclusion criteria
* pregnant or lactating female, * long-term opioids or sedative medication, * patients \< 18 years of age, * severe bradycardia (HR \< 50 beats/min), * hypotension (systolic pressure \< 90mmHg), * any type of atrioventricular block on the ECG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopy Scores | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Blood Pressure | 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 | 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. |
| Patient's Reaction to Procedure | 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 1. Patient is anxious and agitated or restless, or both 2. Patient is cooperative, oriented and tranquil 3. Patient responds to commands only 4. Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus 5. Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus 6. Patient exhibits no response to stimuli |
| Cardiac Rhythm | 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 | 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 1. Cooperative, obeying commands 2. Uncomfortable, GA imminent 3. Other（specify） |
| Peripheral Oxygen Saturation(SPO2) | 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. |
| Post Operative Visit | 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. |
Countries
China
Participant flow
Recruitment details
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
One patient declined consent and one operation was cancelled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Remifentanil Target Controlled Infusion | Dexmedetomidine Infusion for Sedation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 37.8 years STANDARD_DEVIATION 14.9 | 39.4 years STANDARD_DEVIATION 15.2 | 38.6 years STANDARD_DEVIATION 14.8 |
| Region of Enrollment China | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 3 / 20 | 2 / 20 |
Outcome results
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
Time frame: during the procedure of fibreoptic and tracheal intubation
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Endoscopy Scores | 3 units on a scale |
| Dexmedetomidine Continuously Infusion for Sedation | Endoscopy Scores | 2 units on a scale |
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
Time frame: during the inserting of the tracheal tube
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Intubation Score | 1 units on a scale |
| Dexmedetomidine Continuously Infusion for Sedation | Intubation Score | 1 units on a scale |
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.
Time frame: 15 minutes before intubation and duration of intubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Cardiac Rhythm | 2 participants |
| Dexmedetomidine Continuously Infusion for Sedation | Cardiac Rhythm | 3 participants |
Secondary
Heart Rate
Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Time frame: 15 minutes before intubation, endoscopy point, intubation point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remifetanil Target Controlled Infusion | Heart Rate | Heart rate15 minutes before intubation | 76.4 beats per minute | Standard Deviation 11.7 |
| Remifetanil Target Controlled Infusion | Heart Rate | Heart rate at endoscopy point | 76.9 beats per minute | Standard Deviation 15.9 |
| Remifetanil Target Controlled Infusion | Heart Rate | Heart rate at intubation point | 77.8 beats per minute | Standard Deviation 15.3 |
| Dexmedetomidine Continuously Infusion for Sedation | Heart Rate | Heart rate15 minutes before intubation | 72.8 beats per minute | Standard Deviation 10.2 |
| Dexmedetomidine Continuously Infusion for Sedation | Heart Rate | Heart rate at endoscopy point | 56.5 beats per minute | Standard Deviation 9.5 |
| Dexmedetomidine Continuously Infusion for Sedation | Heart Rate | Heart rate at intubation point | 65.4 beats per minute | Standard Deviation 9.8 |
Secondary
Mean Arterial Blood Pressure
MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Time frame: 15 minutes before intubation, endoscopy point, intubation point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remifetanil Target Controlled Infusion | Mean Arterial Blood Pressure | MAP at 15 minutes before intubation | 93.8 mmHg | Standard Deviation 10 |
| Remifetanil Target Controlled Infusion | Mean Arterial Blood Pressure | MAP at endoscopy point | 102.8 mmHg | Standard Deviation 10.5 |
| Remifetanil Target Controlled Infusion | Mean Arterial Blood Pressure | MAP at intubation point | 101.3 mmHg | Standard Deviation 14.5 |
| Dexmedetomidine Continuously Infusion for Sedation | Mean Arterial Blood Pressure | MAP at intubation point | 103.5 mmHg | Standard Deviation 9.9 |
| Dexmedetomidine Continuously Infusion for Sedation | Mean Arterial Blood Pressure | MAP at 15 minutes before intubation | 90.4 mmHg | Standard Deviation 10.6 |
| Dexmedetomidine Continuously Infusion for Sedation | Mean Arterial Blood Pressure | MAP at endoscopy point | 99.5 mmHg | Standard Deviation 10.7 |
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 1. Patient is anxious and agitated or restless, or both 2. Patient is cooperative, oriented and tranquil 3. Patient responds to commands only 4. Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus 5. Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus 6. Patient exhibits no response to stimuli
Time frame: the duration of intubation, an expected average of 10 minutes
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Patient's Reaction to Procedure | 3 units on a scale |
| Dexmedetomidine Continuously Infusion for Sedation | Patient's Reaction to Procedure | 3 units on a scale |
Secondary
Peripheral Oxygen Saturation(SPO2)
Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Time frame: 15 minutes before intubation, endoscopy point, intubation point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remifetanil Target Controlled Infusion | Peripheral Oxygen Saturation(SPO2) | 15 minutes before intubation | 99.0 percentage oxygen saturation | Standard Deviation 1.2 |
| Remifetanil Target Controlled Infusion | Peripheral Oxygen Saturation(SPO2) | at intubation point | 98.2 percentage oxygen saturation | Standard Deviation 1.9 |
| Remifetanil Target Controlled Infusion | Peripheral Oxygen Saturation(SPO2) | at endoscopy point | 95.8 percentage oxygen saturation | Standard Deviation 2.6 |
| Dexmedetomidine Continuously Infusion for Sedation | Peripheral Oxygen Saturation(SPO2) | at endoscopy point | 98.2 percentage oxygen saturation | Standard Deviation 2 |
| Dexmedetomidine Continuously Infusion for Sedation | Peripheral Oxygen Saturation(SPO2) | at intubation point | 99.0 percentage oxygen saturation | Standard Deviation 1.4 |
| Dexmedetomidine Continuously Infusion for Sedation | Peripheral Oxygen Saturation(SPO2) | 15 minutes before intubation | 98.9 percentage oxygen saturation | Standard Deviation 1.1 |
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 1. Cooperative, obeying commands 2. Uncomfortable, GA imminent 3. Other（specify）
Time frame: immediately after the intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Post Intubation Score | 1 units on a scale |
| Dexmedetomidine Continuously Infusion for Sedation | Post Intubation Score | 1 units on a scale |
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.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifetanil Target Controlled Infusion | Post Operative Visit | 13 participants |
| Dexmedetomidine Continuously Infusion for Sedation | Post Operative Visit | 6 participants |