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NCT Number: NCT04688203

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

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.

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Key information

Conditions

Peripheral Perfusion Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alshaimaa Abdel Fattah Kamel

Zagazig, 002055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium Sulfate Injection

Drug

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.

Other names: magnesium sulfate

Labetalol Injectable Solution

Drug

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.

Other names: labetalol

Primary outcomes

  1. Peripheral perfusion index

    Time frame: Changes from baseline Peripheral perfusion index at 2 hours.

    Peripheral perfusion index by pulse oximertry will be measured at basal, 3minutes after induction, every 10 minutes till end of surgery. It will be calculated by dividing the pulsatile signal to nonpulsatile. The normal range is (0.02% -20%)

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery

    Mean arterial blood pressure will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.

  2. Heart rate

    Time frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery

    Heart rate will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.

  3. postoperative Pain intensity

    Time frame: at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative.

    Postoperative Pain will be assessed using Numerical rating Scale (NRS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient will be instructed to make a mark along the line to represent the intensity of pain currently being experienced. NRS score 4 or more =pain. Paracetamol 1gm IV will be given every 6 hours as a protocol for pain management will be started at the end of surgery, and IV pethidine 1mg/kg (rescue analgesic) will be given if NRS >4.

  4. time to first call for pethidine (rescue analgesic)

    Time frame: up to 24hour postoperative

    Time from the stoppage of infusion solution to first call for pethidine (rescue analgesic) will be recorded.

  5. Total pethidine requirements

    Time frame: up to 24hour postoperative

    Total pethidine requirements

  6. Serum lactate level

    Time frame: basal and at one hour after extubation

    Serum lactate will be recorded basal and at one hour after extubation. The normal serum lactate ranges from 4.5 to 19.8 mg/dL

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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