Controlled Hypotension During Functional Endoscopic Sinus Surgery

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Hemorrhage

Treatments: Drug: Magnesium Sulfate; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01956981

2011-221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Magnesium

Placebo Comparator group

Description:

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.

Treatment:

Drug: Magnesium Sulfate

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine