The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

Kaohsiung Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Awake Fiberoptic Nasal Intubation

Treatments: Drug: propofol 1%; Drug: dexmedetomidine; Drug: Normal Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT00815893

KMUHIRB-96-09-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

60 participants in 3 patient groups, including a placebo group

1 dex group

Experimental group

Description:

received dexmedetomidine (1.0 mcg/kg) infusion

Treatment:

Drug: dexmedetomidine

2 control group

Placebo Comparator group

Description:

received 0.9% saline

Treatment:

Drug: Normal Saline 0.9%

3 Propofol group

Active Comparator group

Description:

received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)

Treatment:

Drug: propofol 1%