Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- grading scores presenting conditions for nasal intubation
Study Overview
Brief Summary
The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.
Detailed Description
Case number: 60, ASA I-III oral cancer patients with limited mouth opening
Patients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI.
Main outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction.
Other analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Head and neck cancer patients with limited mouth opening
- •Undergoing awake fiberoptic nasal intubation for elective surgery
Exclusion Criteria
- •a history of severe bradycardia
- •any type of A-V block in EKG
- •heart failure
- •liver cirrhosis
- •thrombocytopenia
- •coagulopathy
Arms & Interventions
1 dex group
received dexmedetomidine (1.0 mcg/kg) infusion
Intervention: dexmedetomidine (Drug)
2 control group
received 0.9% saline
Intervention: Normal Saline 0.9% (Drug)
3 Propofol group
received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)
Intervention: propofol 1% (Drug)
Outcomes
Primary Outcomes
grading scores presenting conditions for nasal intubation
Time Frame: before and after intubation
Secondary Outcomes
No secondary outcomes reported