Phase 4 N=40 Randomized Quadruple-blind Supportive Care

Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Intubation; Difficult

Bottom Line

View on ClinicalTrials.gov: NCT01474213 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Nov 2012

Primary outcome: Primary: Endoscopy Scores — 3; 2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: dexmedetomidine group (Drug); remifentanil group (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Endoscopy Scores	3; 2	—
PRIMARY Intubation Score	1; 1	—
SECONDARY Patient's Reaction to Procedure	3; 3	—
SECONDARY Post Operative Visit	13; 6	—
SECONDARY Mean Arterial Blood Pressure	101.3; 103.5; 93.8; 90.4; 102.8; 99.5	—
SECONDARY Heart Rate	76.4; 72.8; 76.9; 56.5; 77.8; 65.4	—
SECONDARY Peripheral Oxygen Saturation(SPO2)	99.0; 98.9; 95.8; 98.2; 98.2; 99.0	—
SECONDARY Cardiac Rhythm	2; 3	—
SECONDARY Post Intubation Score	1; 1	—

Summary

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01474213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.