Current partner codePEPTIDESDE
NCT05774067·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

135

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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

Interventions

Treatment arms and agents.

DRUG

Saline

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

DRUG

Norepinephrine

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

DRUG

glypressin

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

Timeline

From registration to results.

  1. First posted

    Mar 17, 2023

  2. Study start

    Dec 1, 2022

  3. Primary completion

    Jun 30, 2023

  4. Study completion

    Jul 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Nov 22, 2023

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

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