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CompletedNCT05774067Updated Nov 22, 2023

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

An interventional study of Saline and Norepinephrine in Norepinephrine, Glypressin, Tourniquet Deflation and Hypotension, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Tanta University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Norepinephrine, Glypressin, Tourniquet Deflation
  • Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 135 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
135 participants (actual)

Study arms

  • Active comparator
    control

    Drug: Saline

  • Active comparator
    noradrenaline

    Drug: Norepinephrine

  • Active comparator
    glypressin

    Drug: glypressin

Interventions

  • DrugSaline

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

    Also known as: control

  • DrugNorepinephrine

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

    Also known as: noradrenaline

  • Drugglypressin

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

    Also known as: vasopressin

06

What researchers measure

Primary outcomes

  1. change of mean arterial blood pressure

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

    Time frame: 30 minutes after tourniquet deflation

07

Study locations

1 site
  • Faculty of medicine, Tanta university
    Tanta, El Gharbyia 31111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05774067
Lead sponsor
Tanta University
Responsible party
tarek abdel hay mostafa (principle investigator, Tanta University) — Principal investigator
First posted
Mar 17, 2023
Start date
Dec 1, 2022
Primary completion
Jun 30, 2023
Completion
Jul 30, 2023
Last update
Nov 22, 2023

Study contacts

reda sobhy, MD
study director · tanta university, faculty of medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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