Controlled Hypotension During Functional Endoscopic Sinus Surgery

Phase 4

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Magnesium Sulfate; Drug: Dexmedetomidine

• Registration Number: NCT01956981
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

Detailed Description

Background: 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.

Methods: Sixty patients aged between 18-65 years were enrolled. Patients were divided into two groups. In the magnesium sulfate group (Group M) patients were administered 40 kg-1 magnesium sulfate in 100 ml saline solution in 10 minutes as IV loading dose 10 minutes before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. In the dexmedetomidine group (Group D) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1 dexmedetomidine during the surgery. Deliberate hypotension was defined as a mean arterial pressure (MAP) being 60-70 mmHg.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Study First Submitted: 2013-09-28
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	Magnesium Sulfate	40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.
Dexmedetomidine	Dexmedetomidine	1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.

Primary Outcome Measures

Name	Time	Method
visibility scale of the surgical site	every 5 minutes during surgery up to 60 minutes	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

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	up to 24 hours	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.