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.: PACTR201907882088179 Date of Approval: 11/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Automatic control versus Target controlled infusion . During liver Resection among Cirrhotic Patients
Official scientific title Automatic control of end-tidal of Inhalational Anaesthetics Concentration versus Target controlled infusion of propofol During liver Resection among Cirrhotic Patients
Brief summary describing the background and objectives of the trial Patients suffering from liver cirrhosis are among the group of patients in need for these new inhalational anaesthetic agents as Sevoflurane and Desflurane. Recently, most of the modern anaesthesia machines became programmed with advanced software to help reduce further the inhalational agents consumption utilizing minimal flow. Automatic Gas Control (AGC) of inhalational anaesthetic agent has been proposed as a new technique applying for both cost-effectiveness and safety concerns. 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) has become increasingly popular in clinical practice
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 01/06/2020
Anticipated target sample size (number of participants) 50
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Automatic Gas Control of sevoflurane group Target end tidal sevoflurane % (EtSEV) set to 1.5–2% with FiO2 of 0.4. allover the surgery be ventilated with the FLOW-I anaesthesia machine (MAQUET, Solna, Sweden) equipped with AGC® software which is the FLOW-i's automated low flow tool that controls the inspired O2 (FIO2) and end-expired inhalational anaesthesia agent concentration (FA) while (by design) exponentially decreasing fresh gas flow (FGF) during wash-in to a maintenance default FGF of 300 mL/ min-1. It also offers a choice of wash-in speeds for the inhaled agents 25 Active-Treatment of Control Group
Experimental Group target control infusion Target plasma concentration of 4 µg/ml will be adjusted all time of operation anaesthesia will be maintained using Injectomat TIVA Agilia (Fresenius kabi syringe pump) ,using 50ml syringe of propofol (Fresenius kabi, Germany) with dilution 10mg/ml, Marsh pharmacokinetic model parameters ( age ,weight , target plasma concentration) will be adjusted. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult liver cirrhotic patients aged 18 to 70 year undergoing liver resection. 2. American Society of Anaesthesiologists physical status class I-II 3. Child Pugh Classification A or B 1. Any central nervous system disease. 2. Severe haemodynamic instability during surgery. 3. Patients in need for re-operation. 4. Unwilling to participate in the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 01/04/2019 national liver institute institution review board
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar menofiya 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the Economic impact of adopting the AGC software compared to TCI on inhalational agent ,propofol consumption (ml/h), (both guided by anaesthesia depth monitor), and Sodalime consumption during major liver resection and length of hospital stay end of operation
Secondary Outcome compare between them as regards effect on systemic haemodynamics, systemic vascular resistance(SVR), number of Anaesthetist interventions (button press), the safety and incidence of hypoxia and/or hypercapnia, the ability to preserve temperature during surgery and in recovery, incidence of postoperative nausea and vomiting and hepatocellular & kidney functions during surgery, at the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar menofiya 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar menufia 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghafar menofiya 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hatem Amin Attallah yassen abdelghafar menufia 23456 Egypt
Khaled Ahmed Yassen yassen abdelghafar menufia 23456 Egypt
Safaa Mohamed Helal yassen abdelghafar menufia 23456 Egypt
Yasmeen Abd Elsalam Kamel yassen abdelghafar menufia 23456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noura adel noura_adel2018@hotmail.com 00201095125130 yassen abdelghafar
City Postal code Country Position/Affiliation
menofiya 23456 Egypt resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 00201095125130 yassen abdelghafar
City Postal code Country Position/Affiliation
menofiya 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Scientific Enquiries Noura adel noura_adel2018@hotmail.com 00201095125130 yassen abdelghafar
City Postal code Country Position/Affiliation
menofiya 23456 Egypt resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the paper will be written after results completion and trying to publish in anasthesia international journal Study Protocol about one year after completiom of study according individual journal guide line
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