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Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

NCT ID: NCT01474213

Last Updated: 2012-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation; Difficult

Keywords

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dexmedetomidine remifentanil awake nasotracheal fibreoptic intubation oral maxillofacial surgery difficult airway adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine

a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h

Group Type ACTIVE_COMPARATOR

dexmedetomidine group

Intervention Type DRUG

1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine

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.

Group Type ACTIVE_COMPARATOR

remifentanil group

Intervention Type DRUG

target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Interventions

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dexmedetomidine group

1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine

Intervention Type DRUG

remifentanil group

target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Hydrochloride Injection Remifentanil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Rong Hu

consultant in anesthesilogy department of Shanghai 9th People's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Jiang, MD, PHD

Role: STUDY_CHAIR

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

Locations

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Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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JYMZK-002

Identifier Type: -

Identifier Source: org_study_id