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Completed

NCT Number: NCT05774067

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Saline

Drug

patient received normal saline 4ml/kg/hr with deflation of tourniquet

Other names: control

norepinephrine

Drug

patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet

Other names: noradrenaline

glypressin

Drug

patient receive glypressin infusion at rate 2 mcg/kg/hr.

Other names: vasopressin

Primary outcomes

  1. change of mean arterial blood pressure

    Time frame: 30 minutes after tourniquet deflation

    change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Nov 22, 2023

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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