Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rong Hu, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier:
NCT01474213
First received: October 31, 2011
Last updated: October 22, 2012
Last verified: October 2012

October 31, 2011
October 22, 2012
November 2011
January 2012   (final data collection date for primary outcome measure)
  • Endoscopy Scores [ Time Frame: during the procedure of fibreoptic and tracheal intubation ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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
Patient's reaction to procedure [ Time Frame: the duration of intubation, an expected average of 10 minutes ] [ Designated as safety issue: No ]
intubation score fibreoptic endoscopy score Ramsay score
Complete list of historical versions of study NCT01474213 on ClinicalTrials.gov Archive Site
  • Patient's Reaction to Procedure [ Time Frame: the duration of intubation, an expected average of 10 minutes ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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)
  • post operative visit [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    memory of endoscopy memory of intubation evaluate pain of intubation
  • NIBP [ Time Frame: 15 minutes before intubation, duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • HR [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • RR [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • Oxygen Saturation [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • continuous ECG [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • End tidal carbon dioxide [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
  • Cardiac rhythm [ Time Frame: 15 minutes before intubation and duration of intubation ] [ Designated as safety issue: Yes ]
    15 minutes before intubation, endoscopy point, intubation point
Not Provided
Not Provided
 
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Intubation; Difficult
  • 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
  • Drug: remifentanil group
    target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
    Other Name: Remifentanil
  • Active Comparator: dexmedetomidine
    a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h
    Intervention: Drug: dexmedetomidine group
  • 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.
    Intervention: Drug: remifentanil group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01474213
JYMZK-002
Yes
Rong Hu, Shanghai 9th People's Hospital
Shanghai 9th People's Hospital
Not Provided
Study Chair: Hong Jiang, MD, PHD Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
Shanghai 9th People's Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP