Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty

Pneumatic tourniquet is usually used in orthopedic surgeries, as it helps to decrease operative bed bleeding, and thus, maintaining a clean and dry surgical field allowing easy and clear identification of the anatomical structures. Despite that advantage, after its deflation, there is a blood volume shift towards that ischemic area, which may decrease cardiac preload leading to hypotension

Study Overview

• Status: Completed
• Conditions: Hypotension; Norepinephrine, Glypressin, Tourniquet Deflation
• Intervention / Treatment: Drug: Saline; Drug: Norepinephrine; Drug: glypressin

Detailed Description

Hemodynamic changes after tourniquet deflation include; hypotension, tachycardia and increase in cardiac index. These changes may be insignificant for healthy individuals but, risky for patients with compromised cardiovascular system and geriatric population.

Hypovolemia is a common problem in many clinical situations. The mortality of hypovolemic shock is directly related to the severity and duration of organ hypoperfusion.

Management of hypotension include frequent monitoring of blood pressure, fluid therapy, non-pharmacological methods, and vasopressors. Fluid therapy by crystalloids or colloids has been the traditional approach to restore volume and can be given as preload or co-load .Non pharmacological methods include positioning and leg compression. Trendelenburg position can increase venous return to the heart. Leg compression by flexion of the hip, elastic bandages, or stockings. An efficient method to treat spinal hypotension is administration of vasopressors, either given by infusion or boluses. Vasopressor drugs act by reversing the circulatory effect of sympathetic blockade. They also restore vascular tone and preserve venous return and cardiac filling

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31111
      • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult Patients of both gender
• American Society of Anesthesiologists (ASA) I or II
• scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria

• Patient refusal.
• Major cardiopulmonary disorders
• Uncontrolled systemic hypertension.
• Hepatic or renal disorders.
• Patient with relative contraindication for tourniquet use as peripheral vascular disease, sickle cell anemia, deep venous thrombosis, diabetic neuropathy and crushed injury.
• Cases having American Society of Anesthesiologists [ASA] > II
• Coagulopathy and bleeding tendency.
• Revision knee arthroplasty and bilateral knee arthroplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control	Drug: Saline; patient received normal saline 4ml/kg/hr with deflation of tourniquet; Other Names: control
Active Comparator: noradrenaline	Drug: Norepinephrine; patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet; Other Names: noradrenaline
Active Comparator: glypressin	Drug: glypressin; patient receive glypressin infusion at rate 2 mcg/kg/hr.; Other Names: vasopressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of mean arterial blood pressure	change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.	30 minutes after tourniquet deflation

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: reda sobhy, MD, tanta university, faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Hemostatics; Coagulants; Sympathomimetics; Vasoconstrictor Agents; Antidiuretic Agents; Norepinephrine; Vasopressins; Terlipressin
• Other Study ID Numbers: tourniquet deflation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No