Hemorrhage Clinical Trial
Official title:
Comparison Between Magnesium Sulfate and Dexmedetomidine in Controlled Hypotension During Functional Endoscopic Sinus Surgery: A Double-blind, Randomized Clinical Trial
Verified date | October 2013 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
It is very important to decrease the bleeding during functional endoscopic sinus surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 18 and 65 years scheduled for functional endoscopic sinus surgery Exclusion Criteria: - Patients with kidney, liver, hematological and neuromuscular diseases, diabetic neuropathy, any known allergy history to studied agents. - weight exceeding the ideal body weight more than 30%, - Being treated with calcium channel blockers, non-steroidal anti-inflammatory drugs, agents affecting neuromuscular blockage,and agents contraindicated for controlled hypotension |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visibility scale of the surgical site | Surgical site was rated according to 6 point scale at every 5 minutes by the same surgeon in terms of bleeding and dryness during surgery | every 5 minutes during surgery up to 60 minutes | No |
Secondary | Blood Pressure | After the patients were taken to the operating room, mean arterial pressure (MAP)was monitored and data was measured at every 5 minutes. Hemodynamic data were recorded at the initial phase, after the induction, 5, 10, 15, 30 and 45 minutes after the intubating, 1 and 5 minutes after the extubating. | up to 24 hours | No |
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