Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003900400089 Date of Approval: 17/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title tournique deflation and its effect on haemodynamics
Official scientific title Gradual versus intermittent release of tourniquet in total knee arthroplasty surgery: prospective randomized controlled study.
Brief summary describing the background and objectives of the trial Tourniquet use is a common practice in total knee arthroscopy, deflation greatly affect haemodynamics and acid base balance. Different deflation way were prescribed aiming to attenuate this effect and keep patient stable during this critical time. In this clinical trial we will study two manners of tourniquet deflation and their clinical implication on haemodynamics and acid base parameters on orthopedic patients undergoingtotal knee arthroplasty surgery under regional anaesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) tournique release
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/02/2020
Actual trial start date
Anticipated date of last follow up 25/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intermitent release of tournique 3 cycles (deflation for 10 seconds then reinflate the tournique for 50 second for each one cycle) starting after completion of surgical procedure 3 minutes( 3 cycle each cycle for 1 minute) after completion of surgical procedure we will start tourniquet release, 3 cycle of deflation reinflation , each cycle 60 second( deflation last for 10 second and reinflation for 50 second), after these 3 cycles complete tourniquet release will be done 30
Control Group gradual tourniquet release release of tourniquet by rate 50 mmhg/30 sec till complete relase within 3 minutes 3 minutes after completion of surgical procedure, tourniquet deflation by rate 50 mmhg/30 sec till complete relase within 3 minutes 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults both sex ASA I or II aging >40 years undergoing total knee arthroplasty surgery in mansoura university hospitals 1-Patient refusal 2-Major cardiopulmonary disorders 3-Hepatic or renal disorders 4-Patient with relative contraindication for tourniquet use (as peripheral vascular disease, sickle cell anemia, deep venous thrombosis, diabetic neuropathy and crushed injury) Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/02/2020 IRB manoura university
Ethics Committee Address
Street address City Postal code Country
elgomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean arterial blood pressure( MABP). 0,1,2,3min during deflation, 1-5-30 min post deflation
Secondary Outcome HR, MABP, Spo2, Respiratory rate 0,1,2,3 min during deflation, 1-5-30 min post deflation
Secondary Outcome PH, PCO2, PO2, K, serum lactate 5-30 min post deflation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abouelela khatab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university egypt elgomhoria elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria streeet elmansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed abouelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university egypt
Role Name Email Phone Street address
Public Enquiries mohamed abouelela aboelea_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university egypt
Role Name Email Phone Street address
Scientific Enquiries rania elbadrawy rania_m_badrawy@yahoo.com 00201003689480 el ebor street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study design, methodolgy, results Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 month after completion of study through IRB mansoura university
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information