Phase 4
Completed N=40
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
Intubation; Difficult
Source: ClinicalTrials.gov NCT01474213 ↗
Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Nov 2012
Primary outcomePrimary: Endoscopy Scores — 3; 2 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.