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

Last updated: February 23, 2022
Sponsor: Zagazig University
Overall Status: Completed

Phase

1/2

Condition

Acute Pain

Pain

Post-surgical Pain

Treatment

N/A

Clinical Study ID

NCT04688203
6601
  • Ages 21-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 sinussurgery and polypectomy.
  • Duration of surgery ≤ two hours.

Exclusion

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.

Study Design

Total Participants: 50
Study Start date:
February 01, 2021
Estimated Completion Date:
September 30, 2021

Study 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.

Connect with a study center

  • Alshaimaa Abdel Fattah Kamel

    Zagazig, 002055
    Egypt

    Site Not Available

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