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.: PACTR201806003395974 Date of Approval: 19/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of local anaesthesia with lidocaine versus bupivacaine on cognitive function in patients undergoing elective cataract surgery
Official scientific title Effect of local anaesthesia with lidocaine versus bupivacaine on cognitive function
Brief summary describing the background and objectives of the trial Much Concern has been raised about the effects of anaesthetic drugs on cognition. Postoperative cognitive dysfunction may manifest as impairment in attention, memory, language or executive functions following surgery, and can persist for weeks, months, or more with varying severity. Such post operative cognitive dysfunction can be quite mild and only diagnosed through psychometric assessment using specific neuropsychological tests. Postoperatively, the patients may find some difficulties in resuming their normal activities, discover problems with recalling recent events, forget appointments, names and phone numbers. Such deterioration may have serious consequences on the patient¿s ability to work. Postoperative cognitive decline occurs more frequently in the elderly population with an incidence as high as 26% in patients older than 60 years and it can persist more than one week. The factors that have been implicated in increasing the risk of postoperative cognitive dysfunction include duration of surgery, pain, old age, preoperative impairment in neurocognitive function, hypoxemia, metabolic disturbances, and use of certain anesthetics Multiple clinical trials have attempted to differentiate the effect of general versus regional anaesthesia on cognitive function. While most of the studies showed no difference in post operative cognitive function between regional and general anaesthesia, some trials showed a significant difference in post-operative cognitive outcomes between both anaesthetic techniques. no studies compared the risk of post operative cognitive dysfunction following different types of local anaesthetics. The objective of this work is to: Determine which of the two local anaesthetics (lidocaine vs bupivacaine) has worse effect on cognitive function in patients undergoing elective cataract surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cataract,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 31/05/2018
Actual trial start date 31/05/2018
Anticipated date of last follow up 31/07/2018
Actual Last follow-up date 31/07/2018
Anticipated target sample size (number of participants) 61
Actual target sample size (number of participants) 61
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group lidocaine lidocaine 2% with total volume 7 ml preoperative patients will be injected preoperatively with lidocaine 2% 28 Active-Treatment of Control Group
Experimental Group bupivacaine total volume 7 ml preoperative patients will be injected preoperatively with bupivacaine 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients candidate for elective cataract surgery by phacoemulsification under local anaesthesia, 28 patients will receive lidocaine 2% and 33 patients will receive bupivacaine 0.5%. 2. The patients should provide signed written informed consent to participate. 1. Patients with major language disturbance or auditory impairment affecting their ability to complete testing 2. Patients with pre-existing cognitive, psychiatric or central nervous system disorders 3. Patients with nystagmus, 4. Patients with allergy to local anaesthetics, intravenous sedation, 5. Patients with any coexisting ocular conditions that could affect the scoring system for local anaesthesia such as ptosis, ocular movement abnormality, reduced corneal sensation, or facial nerve palsy, 6. Inability to understand the information about the study 7. if the patient refused the local anaesthesia technique Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 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 08/03/2018 Faculty of medicine, Beni-university, Research ethical committee
Ethics Committee Address
Street address City Postal code Country
salah salem street Beni-suef 62511 Egypt
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 08/03/2018 Faculty of medicine, Beni-university, Research ethical committee
Ethics Committee Address
Street address City Postal code Country
salah salem street Beni-suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cognitive dysfunction one week
Secondary Outcome motor and sensory function one week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-suef University Salah Salem street Beni-suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni-suef university Salah Salem street Beni-suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni-suef university Salah Salem street Beni-suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ophthalmology unit, Bani-suef university Salah Salem street Beni-suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Fathy drwaelfathy@yahoo.com 01006527133 Salah Salem Street
City Postal code Country Position/Affiliation
Beni-suef 62511 Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Public Enquiries Husam Khalil khalil_hossam@hotmail.com 01227458864 salah salem street
City Postal code Country Position/Affiliation
Beni-suef 62511 Egypt Assistant proffessor
Role Name Email Phone Street address
Scientific Enquiries mona hussein mona.neuro@yahoo.com 01005131318 Salah Salem Street
City Postal code Country Position/Affiliation
Beni-suef 62511 Egypt lecturer of neurology
REPORTING
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Result URL Hyperlinks
Changes to trial information