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.: PACTR201708002515324 Date of Approval: 13/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Regional cerebral oxygenation
Official scientific title Different Ventilation Techniques and Hemodynamic Optimization to Maintain Regional Cerebral Oxygen Saturation (rScO2) During Laparoscopic Bariatric Surgery. A Prospective Randomized Interventional Study
Brief summary describing the background and objectives of the trial During pneumoperitoneum (PP), regional cerebral oxygen saturation (rScO2) is decreased due to increased intracranial pressure. Under general anesthesia, head-up position also has been associated with decreased rScO2. We conducted our study to analyze the changes in regional cerebral oxygen saturation in response to different ventilation strategies; inspired oxygen concentration (FiO2), end-tidal carbon dioxide (EtCO2) and positive end expiratory pressure (PEEP) in addition to optimizing mean arterial pressure (MAP) in morbid obese patients subjected to laparoscopic bariatric surgery in the reverse trendelenburg position.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied changes in regional cerebral oxygen saturation rScO2,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 09/03/2016
Actual trial start date 13/03/2016
Anticipated date of last follow up 12/04/2017
Actual Last follow-up date 20/04/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 Randomization of the patients was performed according to a computer-generated randomization code. The sequence of randomization was concealed using sequentially numbered opaque envelopes. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group FiO2 1.0 (inspired oxygen concentration ) once 10 min 10 min after raise FiO2 to 1.0 % 25
Control Group MAP/BL (mean arterial pressure/baseline) once 10 min MAP back to baseline during supine position 25
Experimental Group FiO2 1.0 (inspired oxygen concentration ) once 10 min 10 min after raise FiO2 to 1.0 % 25
Control Group MAP/BL (mean arterial pressure/baseline) once 10 min MAP back to baseline during supine position 25
Experimental Group FiO2 1.0 (inspired oxygen concentration ) once 10 min 10 min after raise FiO2 to 1.0 % 25
Control Group MAP/BL (mean arterial pressure/baseline) once 10 min MAP back to baseline during supine position 25
Experimental Group FiO2 1.0 (inspired oxygen concentration ) once 10 min 10 min after raise FiO2 to 1.0 % 25
Control Group MAP/BL (mean arterial pressure/baseline) once 10 min MAP back to baseline during supine position 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age >18 years, with a body mass index (BMI) of ¿ 30 kg/m2 ASA physical status II. forced expiratory volume in 1st second (FEV1) <50% of predicted values, cerebrovascular disease, poorly controlled hypertension (systolic arterial pressure ¿160¿mmHg), poorly controlled diabetes mellitus (random blood glucose ¿200¿mg/dL) and renal insufficiency (creatinine >1.5¿mg/dL). 18 Year(s) 80 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 10/02/2016 Alkaseralaini local ethical committee
Ethics Committee Address
Street address City Postal code Country
Alkaser alini cairo 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome regional cerebral oxygen saturation 1)Baseline 2)5 min following anesthesia induction 3)10 min after pneumoperitoneum 4)10 min after start PEEP 10 cmH2O 5)10 min after raise FiO2 to 1.0 % 6)10 min after raise EtCO2 up to 40-45 mmHg
Secondary Outcome postoperative recovery at recovery room
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kaseralini hospital Alkaseralini street cairo 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alkaseralini hospital Alkaseralini street cairo 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alkaseralini hospital Alkaseralini street cairo 0000 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Alkaseralini hospital Alkaseralini street cairo 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator osama asaad osamaasaad@yahoo.com 00201223868767 alkaseralini street
City Postal code Country Position/Affiliation
cairo 0000 Egypt Anesthesia consultant
Role Name Email Phone Street address
Public Enquiries Aymen Ahmed draymenahmed@yahoo.com 00201223868767 alkaseralini street
City Postal code Country Position/Affiliation
cairo 0000 Egypt Anesthesia consultant
Role Name Email Phone Street address
Scientific Enquiries osama asaad osamaasaad@yahoo.com 00201223868767 alkaseralini street
City Postal code Country Position/Affiliation
cairo 0000 Egypt Anesthesia consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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