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

Not Applicable

Completed

• Conditions: Norepinephrine, Glypressin, Tourniquet Deflation; Hypotension
• Interventions: Drug: glypressin; Drug: Saline; Drug: Norepinephrine

• Registration Number: NCT05774067
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glypressin	glypressin	-
control	Saline	-
noradrenaline	Norepinephrine	-

Primary Outcome Measures

Name	Time	Method
change of mean arterial blood pressure	30 minutes after tourniquet deflation	change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.

Trial Locations

Locations (1)

Faculty of medicine, Tanta university; 🇪🇬 Tanta, El Gharbyia, Egypt