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

T

Tanta University

Status

Completed

Conditions

Hypotension
Norepinephrine, Glypressin, Tourniquet Deflation

Treatments

Drug: Norepinephrine
Drug: glypressin
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05774067
tourniquet deflation

Details and patient eligibility

About

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

Full 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

Enrollment

135 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

135 participants in 3 patient groups

control
Active Comparator group
Treatment:
Drug: Saline
noradrenaline
Active Comparator group
Treatment:
Drug: Norepinephrine
glypressin
Active Comparator group
Treatment:
Drug: glypressin

Trial contacts and locations

1

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Central trial contact

tarek A Mostafa, MD

Data sourced from clinicaltrials.gov

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