Clinical trial NCT04688203: Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
Official title: Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Perfusion
Postoperative Pain
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral perfusion index
timeFrame: Changes from baseline Peripheral perfusion index at 2 hours.
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
measure: Heart rate
timeFrame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
measure: postoperative Pain intensity
timeFrame: at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative.
measure: time to first call for pethidine (rescue analgesic)
timeFrame: up to 24hour postoperative
measure: Total pethidine requirements
timeFrame: up to 24hour postoperative
measure: Serum lactate level
timeFrame: basal and at one hour after extubation
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Alshaimaa Abdel Fattah Kamel
Study officials:
affiliation: Faculty of Human medicine, Zagazig university
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.