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.: PACTR202310626983365 Date of Approval: 19/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Target controlled infusion for propofol anesthesia during Transjugular Intrahepatic Porto Systemic Shunt procedure
Official scientific title Target controlled infusion for propofol anesthesia during Transjugular Intrahepatic Porto Systemic Shunt procedure: a randomized controlled trial
Brief summary describing the background and objectives of the trial Transjugular intrahepatic portosystemic shunt (TIPS) has been used in cirrhotic patients for the management of Portal Hypertension complications as varices and refractory ascites. TIPS has also been used as a potential treatment for hepatopulmonary syndrome (HPS). Target-controlled infusion (TCI), is an intravenous administration system, which provides desired target plasma concentrations of therapeutic agents and aims to maintain an appropriate depth of anesthesia . TCI is a microprocessor that adjust the infusion rate according to the algorithms based on pharmacokinetic models Aim to study the effectiveness of in sedation in TIPS procedure regarding SEDlines level and sedation related complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TCI in TIPS
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group target controlled infusion It will be(4 μg/mL)in the patient aged over 50 years and (5 μg/mL) in those aged ≤50 years all over the procedure using TCI pump (Injectomat TIVA Agilia, Fresenius Kabi syringe pump). Patient parameters concerning age and weight will be applied to the settings. The initial target of plasma propofol concentration for the each patient will be set according to the age. It will be(4 μg/mL)in the patient aged over 50 years and (5 μg/mL) in those aged ≤50 years using the Marsh pharmacokinetic model. Then the TCI extension line will be connected to the patient and infusion will be started until SEDline target range (25-50) is reached Fentanyl (1-1.5 μg\ kg) bolus will be given and the TIPS procedure will be started. 39
Control Group control group propofol bolus (1 mg/kg),then infusion (170 μg/ kg/min) for 10 minutes using BD Alaris™ CC Plus syringe pump all over the procedure anesthesia will be induced with propofol bolus (1 mg/kg),then infusion (170 μg/ kg/min) for 10 minutes using BD Alaris™ CC Plus syringe pump , and then (130 μg/kg/min) for other 10 minutes while monitoring the SEDline readings to obtain the target range(25-50).When the target level is reached, fentanyl (1-1.5 μg\ kg) will be given and the TIPS procedure will be started. Maintenance of anesthesia will be conducted by infusion of propofol (100 μg/kg/min), increasing of propofol infusion rate (10 μg/kg/min),when SEDline reading exceed the target range to be more than 50,or mean blood pressure and heart rate increase by 20% above the baseline. Also, propofol infusion rate will be decreased by (10 μg/kg/min), when SEDline reading decrease below 25 39 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients from 18 to 60 years from both sex. 2. Patients with American Society of Anesthesia ASA classification II. 3. Patients candidate for TIPS intervention Patients with uncontrolled cardiovascular, respiratory or renal dysfunction. 2. History of allergy to any used anesthetic agent. 3. Morbid obesity with body mass index(BMI ≥40 Kg/m2). 4. Perioperative significant bleeding or hemodynamic instability (e.g Air embolism) will be excluded from the study. 5. Patient refusal to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 01/07/2023 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare sedline reading and level of sedation in TIPS between the groups at induction ,every 10minute , at the end
Secondary Outcome To evaluate the recovery time, profile, total propofol consumption, with recording the patient and interventional radiologist satisfaction. at the end of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Ghoniem New.start5550@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt resident
Role Name Email Phone Street address
Scientific Enquiries Menattallah ali menna80mas@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data.by email or to the intrnational journals which need the data or concerned in target controlled infusion for propofol anesthesia during Transjugular Intrahepatic Porto Systemic Shunt procedure Study Protocol when results be available study protocol and investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia journal 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