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.: PACTR202008584308152 Date of Registration: 24/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of automatic gas control on sevoflurane gas monitor and recovery during pancreatico-duodenectomy operation.
Official scientific title Effects of automatic gas control on sevoflurane gas monitor and recovery during pancreatico-duodenectomy operation.
Brief summary describing the background and objectives of the trial Automatic Gas Control (AGC) of inhalational anesthetic agent a new technique applied for both cost-effectiveness and safety concerns.we evaluate the effect of automatic gas control on sevoflurane gas monitor and recovery during pancreatico-duodenectomy operation compared to the manual low flow anesthetic technique
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 02/03/2020
Actual trial start date 02/03/2020
Anticipated date of last follow up 02/03/2022
Actual Last follow-up date 02/03/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL PUBMED AND SCOPUS INDEX JOURNAL
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
Control Group control group underwent low-flow manually-controlled anesthesia. ALL OPERATION TIME The patient undergoing pancreaticoduodenectomy operation. under general inhalational anesthesia where low-flow anesthesia is .manually-controlled 20 Placebo
Experimental Group experimental group The patient undergoing pancreaticoduodenectomy operation. under general inhalational anesthesia where low-flow anesthesia is .Automatic controlled all operation time The patient undergoing pancreaticoduodenectomy operation. under general inhalational anesthesia where low-flow anesthesia is.Automatic controlled 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
an adult patient undergoing pancreaticoduodenectomy surgery ASA1 or 11 1. Any central nervous system disease. 2. Severe hemodynamic instability during surgery. 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 01/03/2020 National Liver Institute Institution Review Board
Ethics Committee Address
Street address City Postal code Country
sheben el kom shebin el kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the effect of automatic gas control on sevoflurane gas monitor ( FiSev, EtSev, FiO2 %, EtO2 EtCO2 and I CO2). % all time of operation
Secondary Outcome To evaluate the effect of automatic gas control on recovery during pancreaticoduodenectomy operation compared to the manual low flow anesthetic technique all time of the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute menoufia university shebin el kom shebin el kom 0048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded haram- giza giza 865512511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eman naser elthawra haram giza 865512511 Egypt Individual
Primary Sponsor national liver institute shebin el kom shebin el kom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
emad kamel giza giza 865512511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gasser elazab g_elazab@liver.menofia.edu 01280250026 sheben elkom
City Postal code Country Position/Affiliation
sheben el kom 32511 Egypt professor of hepatology
Role Name Email Phone Street address
Public Enquiries hesham maged hesham.maged2011@yahoo.com 0123548537 giza
City Postal code Country Position/Affiliation
giza 865512511 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries emad kamel ekrefaat@gmail.com 01001888550 giza
City Postal code Country Position/Affiliation
giza 865512511 Egypt associate professor of anathesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data were taken and approved for sharing Informed Consent Form The individual participant data were taken and approved for sharing only I and statistical person and if the individual asked for it
URL Results Available Results Summary Result Posting Date First Journal Publication Date
we can see it throw PubMed website 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