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

NCT05774067 | Completed DMC

• 1 other identifier: tourniquet deflation
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Norepinephrine, Glypressin, Tourniquet Deflation; Hypotension

Outcome Measures

Primary Outcomes (1)

• change of mean arterial blood pressure

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

  30 minutes after tourniquet deflation

Study Arms (3)

control

ACTIVE COMPARATOR

Drug: Saline

noradrenaline

ACTIVE COMPARATOR

Drug: Norepinephrine

glypressin

ACTIVE COMPARATOR

Drug: glypressin

Interventions

Saline DRUG

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

Also known as: control

control

Norepinephrine DRUG

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

Also known as: noradrenaline

noradrenaline

glypressin DRUG

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

Also known as: vasopressin

glypressin

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients of both gender
• American Society of Anesthesiologists (ASA) I or II
• scheduled for elective unilateral total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Sodium Chloride; Norepinephrine; Terlipressin; Vasopressins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Lypressin; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• reda sobhy, MD

  tanta university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: December 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)