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.: PACTR202011919392248 Date of Approval: 25/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Can Vena Cava Ultrasound Guided Volume Repletion Prevent general Induced Hypotension in Elderly Patients?
Official scientific title Can Vena Cava Ultrasound Guided Volume Repletion Prevent general Induced Hypotension in Elderly Patients? A mini fluid challenge.
Brief summary describing the background and objectives of the trial Hypotension during anesthesia can cause cognitive decline and even dementia, and is one of the three independent risk factors for patient death within 1 year postoperatively. Therefore, it is essential to minimize or avoid hypotension during IGA. Recently the fluid volume status of the patient can be assessed via ultrasound evaluation of the inferior vena cava (IVC) . The present study is aiming to investigate the prediction effect of IVC on predict post-induction of general anesthesia (IGA) hypotension in older patients.
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 Prevention
Anticipated trial start date 25/07/2020
Actual trial start date 13/08/2020
Anticipated date of last follow up 01/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Active, not 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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group IVC Ultrasonography No fluid challenge before induction of anesthesia. 15 minutes before induction of general anesthesia IVC Ultrasonography measurements will be performed using a curved transducer set to abdominal mode (1-5 MHz; General Electric; GE, “LOGIQ P5" ultrasound machine). IVC variation will be assessed using ultrasound in the long-axis (sagittal) view. IVC diameter will be measured 1 cm distal to its junction with hepatic vein either by 2-D or M modes via a subcostal approach according to the methodology described by the American Society of Echocardiography. A two-dimensional image of the IVC as it enters the right atrium will be first obtained. 50 Placebo
Experimental Group fluid challenge preinduction 500 ml normal saline or ringer solution over 15 min before induction of general anesthesia this group will receive 500 ml normal saline or ringer infusion over 15 min before induction of general anesthesia. Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• American Society of Anesthesiologists physical status (ASA) I-III • Age > 60 year • Patients scheduled for elective surgeries under general anaesthesia. • Patients with cardiac morbidities (impaired contractility with ejection fraction < 40% and tight valvular lesions, unstable angina). • Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat). • Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation < 90% on room air). • Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC). • Body mass index ≥45 kg/m2. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 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 12/08/2020 Research Ethics Committee at faculty of medicine Benha university
Ethics Committee Address
Street address City Postal code Country
BENHA, AL-SAHAA STREET, DIVERTED FROM FARID NADA STREET UNIQUE TO BENHA UNIVERSITY HOSPITALS Benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study 1ry outcome will be to rate the Incidence of hypotension after anesthesia Induction. Hypotension can be diagnosed if one of the following conditions is true: (1) a decrease in mean arterial pressure of > 20% compared to the baseline value (2) mean arterial pressure < 60mmHg 20 minutes after induction of general anesthesia
Secondary Outcome 1- Maximum and minimum IVC diameters Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. 2- Mean arterial blood pressure measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision 2- Heart rate measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision 10 minutes before induction of general anesthesia and 20 minutes after.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha University Hospital BENHA, AL-SAHAA STREET, DIVERTED FROM FARID NADA STREET UNIQUE TO BENHA UNIVERSITY HOSPITALS Benha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Samar Rafik Mohamed Amin 7 Ahmed Maher Street Benha 13511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine at Benha university BENHA, AL-SAHAA STREET, DIVERTED FROM FARID NADA STREET UNIQUE TO BENHA UNIVERSITY HOSPITALS Benha 13518 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samar Ebrahim samar.rafik@gmail.com +1287793991 7 Ahmed Maher street
City Postal code Country Position/Affiliation
Benha Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Enas Mahdy enaswageh@yahoo.com +1029286117 AL-SAHAA STREET, DIVERTED FROM FARID NADA STREET
City Postal code Country Position/Affiliation
Benha Egypt lecturer
Role Name Email Phone Street address
Public Enquiries SAmar Ebrahim samar.rafik@gmail.com +1287793991 7 Ahmed Maher street
City Postal code Country Position/Affiliation
Benha Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Not applicable
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