Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries

Zagazig University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Pain; Peripheral Perfusion

Treatments: Drug: Labetalol Injectable Solution; Drug: Magnesium Sulfate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04688203

6601

Details and patient eligibility

About

One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery.

Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and nitroglycerine had been used but we are in need to investigate its effects on peripheral perfusion.

Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the release of inflammatory mediators from neuronal and immune cells resulting in peripheral and central sensitization significantly affects recovery of patients. Magnesium sulfate and labetalol have analgesic actions besides their hypotensive effects but with different mechanisms.

Full description

To compare between the effects of magnesium sulfate and labetalol infusion during induced hypotension on peripheral perfusion and postoperative pain in nasal surgeries

OBJECTIVES:

To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To calculate the total postoperative rescue analgesic requirements.

Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated into two equal groups (group M and Group L).

Using computer generated randomization table, each group will be 25 patients.

Enrollment: 50 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent from the patient.
• Age: 21-45 years old.
• Sex: both sex (males or females).
• Physical status: ASA 1& II.
• BMI = (20-30 kg/m2).
• Type of operations: elective nasal surgeries such as septoplasty, endoscopic sinus surgery and polypectomy.
• Duration of surgery ≤ two hours.

Exclusion criteria

• Altered mental state
• Patients on beta blocker or with known history of allergy to study drugs.
• Advanced hepatic, renal, cardiovascular or respiratory diseases.
• Diabetic patients.
• Patients receiving anticoagulants or on pain killers.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Magnesium sulfate infudsion

Active Comparator group

Description:

patients will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.

Treatment:

Drug: Magnesium Sulfate Injection

Labetalol infusion

Active Comparator group

Description:

will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.

Treatment:

Drug: Labetalol Injectable Solution