Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation - Full Text View

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Dexmedetomidine Remifentanil hydrochloride Dexmedetomidine hydrochloride

U.S. FDA Resources

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 ] [ 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

Secondary Outcome Measures:

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）

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474213

Locations

China, Shanghai
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200011
Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai, China, 200011

Sponsors and Collaborators

Shanghai 9th People's Hospital

Investigators

Study Chair:

Hong Jiang, MD, PHD

Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

More Information

No publications provided

Responsible Party:	Rong Hu, consultant in anesthesilogy department of Shanghai 9th People's Hospital, Shanghai 9th People's Hospital
ClinicalTrials.gov 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
Health Authority:	China: Food and Drug Administration

Keywords provided by Shanghai 9th People's Hospital:

dexmedetomidine
remifentanil
awake nasotracheal fibreoptic intubation

oral maxillofacial surgery
difficult airway
adult

Additional relevant MeSH terms:

Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on May 19, 2013