Trial Outcomes & Findings for Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation (NCT NCT01474213)

NCT ID: NCT01474213

Last Updated: 2012-11-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 42 participants
• Primary outcome timeframe: during the procedure of fibreoptic and tracheal intubation
• Results posted on: 2012-11-21

Participant Flow

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

One patient declined consent and one operation was cancelled.

Participant milestones

Measure	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Baseline characteristics by cohort

Measure	Dexmedetomidine Infusion for Sedation n=20 Participants 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 n=20 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39.4 years STANDARD_DEVIATION 15.2 • n=5 Participants	37.8 years STANDARD_DEVIATION 14.9 • n=7 Participants	38.6 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment China	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Endoscopy Scores	3 units on a scale Interval 1.0 to 3.0	2 units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Intubation Score	1 units on a scale Interval 1.0 to 3.0	1 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Patient's Reaction to Procedure	3 units on a scale Interval 2.0 to 4.0	3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Post Operative Visit	13 participants	6 participants

SECONDARY outcome

Timeframe: 15 minutes before intubation, endoscopy point, intubation point

MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Mean Arterial Blood Pressure MAP at intubation point	101.3 mmHg Standard Deviation 14.5	103.5 mmHg Standard Deviation 9.9
Mean Arterial Blood Pressure MAP at 15 minutes before intubation	93.8 mmHg Standard Deviation 10.0	90.4 mmHg Standard Deviation 10.6
Mean Arterial Blood Pressure MAP at endoscopy point	102.8 mmHg Standard Deviation 10.5	99.5 mmHg Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Heart Rate Heart rate15 minutes before intubation	76.4 beats per minute Standard Deviation 11.7	72.8 beats per minute Standard Deviation 10.2
Heart Rate Heart rate at endoscopy point	76.9 beats per minute Standard Deviation 15.9	56.5 beats per minute Standard Deviation 9.5
Heart Rate Heart rate at intubation point	77.8 beats per minute Standard Deviation 15.3	65.4 beats per minute Standard Deviation 9.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Peripheral Oxygen Saturation(SPO2) 15 minutes before intubation	99.0 percentage oxygen saturation Standard Deviation 1.2 • Interval 8.0 to 19.0	98.9 percentage oxygen saturation Standard Deviation 1.1 • Interval 9.0 to 17.0
Peripheral Oxygen Saturation(SPO2) at endoscopy point	95.8 percentage oxygen saturation Standard Deviation 2.6	98.2 percentage oxygen saturation Standard Deviation 2.0
Peripheral Oxygen Saturation(SPO2) at intubation point	98.2 percentage oxygen saturation Standard Deviation 1.9	99.0 percentage oxygen saturation Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Cardiac Rhythm	2 participants	3 participants

SECONDARY outcome

Timeframe: 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）

Outcome measures

Measure	Remifetanil Target Controlled Infusion n=20 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.	Dexmedetomidine Continuously Infusion for Sedation n=20 Participants 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.
Post Intubation Score	1 units on a scale Interval 1.0 to 3.0	1 units on a scale Interval 1.0 to 2.0

Adverse Events

Dexmedetomidine Infusion for Sedation

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil Target Controlled Infusion

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexmedetomidine Infusion for Sedation n=20 participants at risk 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 n=20 participants at risk 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.
Cardiac disorders bradycardia	15.0% 3/20 • during the endoscopy and intubation period	10.0% 2/20 • during the endoscopy and intubation period

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jiang Hong

Department of Anaesthetics, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Phone: 86-21-13512122883

Email: hr310@vip.sina.com.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place