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

NCT ID: NCT05774067

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-07-30

Brief Summary

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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

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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

Conditions

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Norepinephrine, Glypressin, Tourniquet Deflation Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

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

noradrenaline

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

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

glypressin

Group Type ACTIVE_COMPARATOR

glypressin

Intervention Type DRUG

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

Interventions

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Saline

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

Intervention Type DRUG

Norepinephrine

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

Intervention Type DRUG

glypressin

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

Intervention Type DRUG

Other Intervention Names

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control noradrenaline vasopressin

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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tarek abdel hay mostafa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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reda sobhy, MD

Role: STUDY_DIRECTOR

tanta university, faculty of medicine

Locations

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Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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tourniquet deflation

Identifier Type: -

Identifier Source: org_study_id