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.: PACTR201907566720877 Date of Registration: 29/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Automatic vs Low Flow Manual Control of End Tidal Inhalational Anaesthetics Concentration During liver Resection among Cirrhotic Patients
Official scientific title Automatic vs Low Flow Manual Control of End Tidal Inhalational Anaesthetics Concentration 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. The use of guided anaesthesia depth monitoring proved to be of benefit as it was found that these hepatic patients consumes less volumes than patients with health livers during similar surgery as hepatic resection Automatic Gas Control (AGC) of inhalational anesthetic agent has been proposed as a new technique applying for both cost-effectiveness and safety concerns. This topic is important nowaday to highlight the importance of using the high technology in order to accommodate the presence of these expensive inhalational anaesthesia agents in 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 01/06/2018
Actual trial start date 01/06/2018
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 Manual anasthesia low-flow manually-controlled anaesthesia. during operation ventilated with the FLOW-ianaesthesia 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- 20 Placebo
Experimental Group Automatic Gas Control the automatic gas control feature was part of the anaesthetic machine intraoperative be ventilated with the FLOW-ianaesthesia 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 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult liver cirrhotic patients aged 18 to 60 year undergoing liver resection. 2. American Society of Anesthesiologists 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(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),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 17/07/2018 faculty of medicine menofiya universty
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 evaluate the Economic impactof adopting the AGC software compared to the manual low flow anaesthetic technique on inhalational agent consumption (ml/h), (both guided by an anesthesia depth monitor), and Sodalime consumption during major liver resection end of operation
Secondary Outcome Effect of AGC on systemic haemodynamics, number of Anaesthesist interventions (button press), the safety and incidence of hypoxia and/or hypercapnia, the ability to preserve temperature during surgery and in recovery end of operation
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
Rehab abd elsamed 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
Khaled Ahmed Yassen yassen abdelghafar menufia 23456 Egypt
nagwa ibraheem mowafy yassen abdelghafar menufia 23456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab Abd El Samed dr.rehab.nabil@gmail.com 00201095125130 yassen abdelghafar
City Postal code Country Position/Affiliation
menofiya 23456 Egypt resident
Role Name Email Phone Street address
Scientific Enquiries Rehab Abd El Samed dr.rehab.nabil@gmail.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 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
menofiya 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the results will be written and discussed with others Study Protocol 1 dec 2019 anasthesia international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
anasthesia international 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