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.: PACTR201601001446303 Date of Approval: 27/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Patient State Index versus Bispectral Index in Cirrhotic Patients undergoing Hepatic Resection: A Controlled Randomized Study
Official scientific title Patient State Index versus Bispectral Index in Cirrhotic Patients undergoing Hepatic Resection: A Controlled Randomized Study
Brief summary describing the background and objectives of the trial Investigating perioperatively the relationship and agreement between BIS and PSI values in cirrhotic and non-cirrhotic patients undergoing liver resection with general anesthesia. The sensitivity and the specificity of the BIS and PSI values with respect to predicting loss of consciousness and emergence from general anaesthesia. Anaesthetic consumption in both BIS and PSI guided protocols in cirrhotic and noncirrhotic patients undergoing hepatic resection. The aim of this work is to study the extent of electrocautery interferences with both BIS and PSI signals during surgery.  
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/11/2015
Actual trial start date 01/11/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Liver cirrhosis: BIS 1¿2 min before the induction of general anaesthesia and throughout the operation The BIS monitor used a conveniently applied self-adhesive EEG electrode strip (Aspect Medical Systems Inc., Newton, MA, USA), which will be positioned on the forehead. Electrode impedance will be maintained at less than 5 kOhm. 15
Experimental Group Liver cirrhosis: PSI 1¿2 min before the induction of general anaesthesia and throughout the operation PSI will be recorded using SEDLine Brain Function Monitor (Masimo, Irvine, CA, USA) to monitor depth of anaesthesia. Utilizing 4 channels of information. 15
Control Group Normal liver function: BIS 1¿2 min before the induction of general anaesthesia and throughout the operation The BIS monitor used a conveniently applied self-adhesive EEG electrode strip (Aspect Medical Systems Inc., Newton, MA, USA), which will be positioned on the forehead. Electrode impedance will be maintained at less than 5 kOhm. 15 Active-Treatment of Control Group
Control Group Normal liver function: PIS 1¿2 min before the induction of general anaesthesia and throughout the operation PSI will be recorded using SEDLine Brain Function Monitor (Masimo, Irvine, CA, USA) to monitor depth of anaesthesia. Utilizing 4 channels of information. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient undergoing liver resection Patients with pre-existing significant neuropsychiatric, cardiac, pulmonary, renal, neuromuscular or electrolyte disorders. BMI greater than 35 kg/m2. Patients using antipsychotics, antidepressants, or alcohol or drug abuse problems. Major intraoperative events (e.g. Severe hemodynamic instability, blood loss). Unwilling to participate in the study. 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
No 01/02/2016 National Liver Institute, IRB
Ethics Committee Address
Street address City Postal code Country
Yaseen abdelghafar Shibin el kom 32513 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative loss of consciousness Postoperatively at emergence from general anaesthesia.
Secondary Outcome Anesthetic consumption Total amount of volatile anesthetic (Sevoflurane) consumed during the operation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdel-Raouf Metwally Yassin abdolghafar Shebin elkoom 32513 Egypt
Khaled Ahmed Yassen Yassin abdolghafar Shebin elkoom 32513 Egypt
Safaa Mohamed Helal Yassin abdolghafar Shebin elkoom 32513 Egypt
Maha Lotfy EL Sheikh Yassin abdolghafar Shebin elkoom 32513 Egypt
Eman Mohammed Badawy Yassin abdolghafar Shebin elkoom 32513 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Metwaly drahmedabdelraouf@yahoo.com 002-01227968325 Yassin Abdelghaffar
City Postal code Country Position/Affiliation
Shebin El Kom 32513 Egypt Professor of Anesthesiology, Intensive Care, Pain Management
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Khaled Yassen kyassen61@hotmail.com 002-010-63080170 Yassin Abdelghaffar
City Postal code Country Position/Affiliation
Shebin El Kom 32513 Egypt Professor of Anesthesiology, Intensive Care, Pain Management
REPORTING
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