Norepinephrine, Glypressin, Tourniquet DeflationNCT05774067
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
A study testing Saline, Norepinephrine and glypressin in people with Norepinephrine, Glypressin, Tourniquet Deflation and Hypotension, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Norepinephrine, Glypressin, Tourniquet Deflation, Hypotension
- What is being tested?
- Saline, Norepinephrine and glypressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients of both gender
- American Society of Anesthesiologists (ASA) I or II
- scheduled for elective unilateral total knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Saline, Norepinephrine, glypressin
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called control
patient received normal saline 4ml/kg/hr with deflation of tourniquet
NorepinephrineDrug
Also called noradrenaline
patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet
glypressinDrug
Also called vasopressin
patient receive glypressin infusion at rate 2 mcg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Not described Receives: Drug: Saline |
| noradrenaline | Active comparator | Not described Receives: Drug: Norepinephrine |
| glypressin | Active comparator | Not described Receives: Drug: glypressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of mean arterial blood pressure
change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.
Measured: 30 minutes after tourniquet deflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norepinephrine, Glypressin, Tourniquet DeflationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
- Investigators
- reda sobhy, MD, Study director, tanta university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774067
- Sponsor's protocol ID
- tourniquet deflation
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05774067
- Acronym / sponsor ID
- tourniquet deflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: Saline |
| noradrenaline | Active comparator | Drug: Norepinephrine |
| glypressin | Active comparator | Drug: glypressin |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patients of both gender
- American Society of Anesthesiologists (ASA) I or II
- scheduled for elective unilateral total knee arthroplasty
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: controlpatient received normal saline 4ml/kg/hr with deflation of tourniquet | Drug | control |
| NorepinephrineAlso: noradrenalinepatient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet | Drug | noradrenaline |
| glypressinAlso: vasopressinpatient receive glypressin infusion at rate 2 mcg/kg/hr. | Drug | glypressin |
Primary outcome
change of mean arterial blood pressure
Time frame: 30 minutes after tourniquet deflation
change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
reda sobhy, MD study director
tanta university, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Norepinephrine and glypressin in people with Norepinephrine, Glypressin, Tourniquet Deflation and Hypotension, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of mean arterial blood pressure (time frame: 30 minutes after tourniquet deflation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.