Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Intubation; Difficult

Treatments: Drug: remifentanil group; Drug: dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT01474213

JYMZK-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: dexmedetomidine group

remifentanil

Active Comparator group

Description:

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.

Treatment:

Drug: remifentanil group