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

NCT04688203 | Completed Phase 1

• 1 other identifier: 6601
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Perfusion; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Peripheral perfusion index

  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%)

  Changes from baseline Peripheral perfusion index at 2 hours.

Secondary Outcomes (6)

• Mean arterial blood pressure

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

• Heart rate

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

• postoperative Pain intensity

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

• time to first call for pethidine (rescue analgesic)

  up to 24hour postoperative

• Total pethidine requirements

  up to 24hour postoperative

Study Arms (2)

Magnesium sulfate infudsion

ACTIVE COMPARATOR

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.

Drug: Magnesium Sulfate Injection

Labetalol infusion

ACTIVE COMPARATOR

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.

Drug: Labetalol Injectable Solution

Interventions

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.

Also known as: magnesium sulfate

Magnesium sulfate infudsion

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.

Also known as: labetalol

Labetalol infusion

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Alshaimaa Abdel Fattah Kamel

Zagazig, 002055, Egypt

Location

Related Publications (1)

• Kamel AAF, Medhat MM, Salem DAE, Naby SMA. Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial. Patient Saf Surg. 2022 Aug 19;16(1):27. doi: 10.1186/s13037-022-00336-7.

  PMID: 35986325 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Labetalol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Officials

• Alshaimaa Kamel, M.D

  Faculty of Human medicine, Zagazig university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia ,and surgical intensive care

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 29, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

EG (1)