search
Back to results

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

Primary Purpose

Norepinephrine, Glypressin, Tourniquet Deflation, Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Saline
Norepinephrine
glypressin
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Norepinephrine, Glypressin, Tourniquet Deflation

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, Tanta universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

control

noradrenaline

glypressin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
March 18, 2023
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT05774067
Brief Title
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
Official Title
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norepinephrine, Glypressin, Tourniquet Deflation, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Title
noradrenaline
Arm Type
Active Comparator
Arm Title
glypressin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
control
Intervention Description
patient received normal saline 4ml/kg/hr with deflation of tourniquet
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
noradrenaline
Intervention Description
patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet
Intervention Type
Drug
Intervention Name(s)
glypressin
Other Intervention Name(s)
vasopressin
Intervention Description
patient receive glypressin infusion at rate 2 mcg/kg/hr.
Primary Outcome Measure Information:
Title
change of mean arterial blood pressure
Description
change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.
Time Frame
30 minutes after tourniquet deflation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tarek A Mostafa, MD
Phone
+20403288260
Email
dr.tarek311@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
reda sobhy, MD
Organizational Affiliation
tanta university, faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, Tanta university
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek Mostafa
Phone
020403332033
Email
dr.tarek311@yahoo.com
First Name & Middle Initial & Last Name & Degree
sameh Ahmed
Email
samehabdelkhalik1982@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs