Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Chronic Sinusitis

Treatments: Drug: propofol and remifentanil; Drug: Propofol and dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01569048

4-2012-0023

Details and patient eligibility

About

Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation.

The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.

Enrollment: 66 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA Ⅰ-Ⅱ
• Aged between 20 and 70 year
• General anesthesia for endoscopic sinus surgery

Exclusion criteria

• Body mass index >30
• Congestive heart failure, Sinus Bradycardia(<50 BPM), Uncontrolled hypertension,
• Coagulopathy
• Drug addiction
• Pregnancy
• Allergic fungal infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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66 participants in 2 patient groups

remifentanil

Active Comparator group

Treatment:

Drug: propofol and remifentanil

dexmedetomidine

Experimental group

Treatment:

Drug: Propofol and dexmedetomidine