Controlled Hypotension During Functional Endoscopic Sinus Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956981
• Other study ID #: 2011-221
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2013
• Last updated: October 7, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Hypotension

Intervention

Drug:
• Magnesium Sulfate
40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.S., 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

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