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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05774067

Collaborator

(none)

135

Enrollment

Location

Arms

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Norepinephrine, Glypressin, Tourniquet Deflation Hypotension	Drug: Saline Drug: Norepinephrine Drug: glypressin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control	Drug: Saline patient received normal saline 4ml/kg/hr with deflation of tourniquet Other Names: control
Active Comparator: noradrenaline	Drug: Norepinephrine patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet Other Names: noradrenaline
Active Comparator: glypressin	Drug: glypressin patient receive glypressin infusion at rate 2 mcg/kg/hr. Other Names: vasopressin

Arm

Intervention/Treatment

Active Comparator: control

Drug: Saline

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

Other Names:

control

Active Comparator: noradrenaline

Drug: Norepinephrine

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

Other Names:

noradrenaline

Active Comparator: glypressin

Drug: glypressin

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

Other Names:

vasopressin

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Tanta university	Tanta	El Gharbyia	Egypt	31111

Sponsors and Collaborators

Tanta University

Investigators

Study Director: reda sobhy, MD, tanta university, faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

tarek abdel hay mostafa, principle investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT05774067

Other Study ID Numbers:

tourniquet deflation

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023