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.: PACTR202204496465842 Date of Approval: 22/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Intraoperative Lidocaine Use during Cardiac Surgeries on the Hemodynamic and the Intraoperative Opioid Drugs Use.
Official scientific title Hemodynamic and Analgesic Effects of Intravenous Infusion of Lidocaine in Patients Undergoing Cardiac Surgeries.
Brief summary describing the background and objectives of the trial Cardiac surgery is associated with severe intraoperative and postoperative pain because of the surgical incision, sternotomy, internal mammary harvesting, fracture of rib and activation of the stress response. The stress response is associated with both chemical and metabolic changes because of its neuronal and hormonal components. There is an increased secretion of CRH, ACTH, cortisol, arginine-vasopressin, adrenaline, and interleukins. These hormones are associated with salt-water retention, hyperglycemia, vasoconstriction, tachycardia and hypertension which have a deleterious effect. There are different methods for pain management after cardiac surgery. The most commonly used is opioid analgesics. Its use is associated with different side effects, like drowsiness, pruritus, respiratory depression, nausea, vomiting, urinary retention, constipation. These side effects may delay recovery and discharge. Continuous intravenous infusion of lidocaine at 1-2 mg/kg/h achieves a nontoxic plasma concentration level below 5 µg/ml. this plasma level decreases sympathetic response, opioid requirements and decreases volatile drugs consumption. It decreases the stress response because of its anti-inflammatory effect by decreasing the production of interleukins. We hypothesize that continuous intraoperative use of lidocaine will leads to a better hemodynamic state with decreased use of opioid and better postoperative outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/02/2019
Actual trial start date 01/12/2020
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 30/12/2021
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lidocaine a bolus dose of 1.5mg/kg then continuous intravenous infusion of 1.5mg/kg/h with 2mg/kg added for the cardiopulmonary bypass priming fluid. started with anesthesia induction and continue till skin closure. Patients will receive a bolus dose of lidocaine (1.5mg/kg) 5 min before induction of anesthesia over 3 min then an infusion will be prepared and started at (1.5mg/kg/h) and terminated after skin closure. A bolus dose of 2mg/kg will be added for the priming fluid in the CPB machine. 35
Control Group saline saline will be given at a bolus dose then a continuous infusion will be given at the same rate and volume as lidocaine. started with anesthesia induction till skin closure. Patients will receive a bolus of saline then continuous infusion will be started in equal volume and rate as lidocaine. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Age from 18 to 60y. -both sex. -ASA physical status II&III. -Patients scheduled for elective cardiac surgery (valve replacement or coronary artery bypass surgery). -Patients refusal. -allergy to the study drug. -emergent cardiac surgery. -redo cardiac surgery. -combined coronary artery bypass surgery/ valve replacement surgery. -ejection fraction less than 40%. -liver disease. 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 09/01/2019 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Mansoura, 60Elgomhoria st, Mansoura University, Faculty of Medicine Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome systolic arterial blood pressure (SABP). baseline SABP, immediately after intubation, after skin incision, after sternotomy and every 15 minutes for maximum 60 minutes in the pre-bypass time.
Primary Outcome diastolic arterial blood pressure baseline DABP, immediately after intubation, after skin incision, after sternotomy and every 15 minutes for maximum 60 minutes in the pre-bypass time.
Primary Outcome mean arterial blood pressure baseline MABP, immediately after intubation, after skin incision, after sternotomy and every 15 minutes for maximum 60 minutes in the pre-bypass time.
Primary Outcome heart rate baseline HR, immediately after intubation, after skin incision, after sternotomy and every 15 minutes for maximum 60 minutes in the pre-bypass time.
Secondary Outcome amount of intraoperative fentanyl used. at the end of the operation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospital 60Elgomhoria st, Mansoura University,Mit Khamis WA Kafr Al Mougi, Mansoura, Dakahlia Governorate. Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsayed Mohamed Hassan Abdelkarime Mansoura, 60Elgomhoria street. Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhouria Street, Mansoura City-35516, Egypt Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator elsayed abdelkarime elsayedabdelkarime@mans.edu.eg 00201065245907 El Gomhouria St, Mit Khamis WA Kafr Al Mougi, Mansoura, Dakahlia Governorate
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries May Badr mayelsherbiny7@gmail.com 00201007193959 El Gomhouria St, Mit Khamis WA Kafr Al Mougi, Mansoura, Dakahlia Governorate
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries elsayed abdelkarime elsayedabdelkarime@mans.edu.eg 00201065245907 El Gomhouria St, Mit Khamis WA Kafr Al Mougi, Mansoura, Dakahlia Governorate
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data collected during the trial will be shared. Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately after publication with no end date. it will be available for anyone who wants to access the study and for any purpose. data will be available indefinitely on my research gate account by name (Elsayed Abdelkarime).
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