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Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

This study has been completed.
Information provided by (Responsible Party):
Rong Hu, Shanghai 9th People's Hospital Identifier:
First received: October 31, 2011
Last updated: October 22, 2012
Last verified: October 2012
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.

Condition Intervention Phase
Intubation; Difficult
Drug: dexmedetomidine group
Drug: remifentanil group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

    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

  • 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

    1. Cooperative, obeying commands
    2. Uncomfortable, GA imminent
    3. Other(specify)

Enrollment: 42
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01474213

China, Shanghai
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
Sponsors and Collaborators
Shanghai 9th People's Hospital
Study Chair: Hong Jiang, MD, PHD Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
  More Information

Responsible Party: Rong Hu, consultant in anesthesilogy department of Shanghai 9th People's Hospital, Shanghai 9th People's Hospital Identifier: NCT01474213     History of Changes
Other Study ID Numbers: JYMZK-002
Study First Received: October 31, 2011
Results First Received: June 6, 2012
Last Updated: October 22, 2012

Keywords provided by Shanghai 9th People's Hospital:
awake nasotracheal fibreoptic intubation
oral maxillofacial surgery
difficult airway

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on April 26, 2017