Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Intubation; Difficult Clinical Trial

Official title:

Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474213
• Other study ID #: JYMZK-002
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2011
• Last updated: October 22, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: Shanghai 9th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Drug:
• dexmedetomidine group
1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine
• remifentanil group
target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Locations

Country	Name	City	State
China	Shanghai JiaoTong University, School of Medicine	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	during the procedure of fibreoptic and tracheal intubation	No
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	during the inserting of the tracheal tube	No
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; 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	the duration of intubation, an expected average of 10 minutes	No
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.	24 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
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.	15 minutes before intubation and duration of intubation	No
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; Cooperative, obeying commands; Uncomfortable, GA imminent; Other(specify)	immediately after the intubation	No