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Controlled Hypotension During Functional Endoscopic Sinus Surgery

Comparison Between Magnesium Sulfate and Dexmedetomidine in Controlled Hypotension During Functional Endoscopic Sinus Surgery: A Double-blind, Randomized Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01956981
Enrollment
60
Registered
2013-10-08
Start date
2012-01-31
Completion date
2013-07-31
Last updated
2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

controlled hypotension, dexmedetomidine, magnesium sulfate.

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.

Interventions

DRUGMagnesium 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.

DRUGDexmedetomidine

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.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visibility scale of the surgical siteevery 5 minutes during surgery up to 60 minutesSurgical 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

MeasureTime frameDescription
Blood Pressureup to 24 hoursAfter 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026