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.: PACTR202103648671596 Date of Approval: 05/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Magnesium Sulphate as an Adjuvant to Local Anesthesia in Single-Injection Percutaneous Peribulbar Anesthesia for Cataract Extraction
Official scientific title Dexmedetomidine versus Magnesium Sulphate as an Adjuvant to Local Anesthesia in Single-Injection Percutaneous Peribulbar Anesthesia for Cataract Extraction
Brief summary describing the background and objectives of the trial Background: Peribulbar block for cataract extraction surgery using the conventional technique & local anesthetic mixture is mostly associated with delayed onset of globe anesthesia, akinesia, and short duration of analgesia with the need for multiple injections and/or large volume of local anesthetic. Objective: To assess & compare the effect of addition of dexmedetomidine vs magnesium sulphate to standard local anesthetics mixtures on the time of onset of Globe Anesthesia, Akinesia & analgesia duration using the single-injection percutaneous technique for peribulbar block.
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 comparison between effectiveness of two different adjuvants to local anesthesia
Anticipated trial start date 21/03/2018
Actual trial start date 20/06/2018
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group C received 3 ml of lidocaine 2% + 3 ml bupivacaine 0.5% + 120 international unit (IU) of hyaluronidase + 0.5 ml of 0.9% normal saline in 10 ml syringe (total volume injected 7 ml) over 10 minutes single-injection percutaneous peribulbar block: After adequate sterilization, all patients received single-injection percutaneous peribulbar block by an experienced anesthesiologist. A 25G beveled 16mm needle was inserted 5mm below the inferior lacrimal punctum along the lower orbital margin, then advanced vertically till half its length then obliquely towards the optic foramen. After gentle negative aspiration, 7ml of the local anesthetic mixture was injected slowly and smoothly. The needle was afterwards gently retracted and gentle digital pressure applied intermittently to facilitate diffusion of the local anesthetic. 20 Active-Treatment of Control Group
Experimental Group Group D received 3 ml of lidocaine 2% + 3 ml bupivacaine 0.5% + 120 international unit (IU) of hyaluronidase + 50 mcg dexmedetomidine in10 ml syringe (total volume injected 7 ml) over 10 minutes Single-injection percutaneous peribulbar block: After adequate sterilization, all patients received single-injection percutaneous peribulbar block by an experienced anesthesiologist. A 25G beveled 16mm needle was inserted 5mm below the inferior lacrimal punctum along the lower orbital margin, then advanced vertically till half its length then obliquely towards the optic foramen. After gentle negative aspiration, 7ml of the local anesthetic mixture was injected slowly and smoothly. The needle was afterwards gently retracted and gentle digital pressure applied intermittently to facilitate diffusion of the local anesthetic. 20
Experimental Group Group M received 3 ml of lidocaine 2% + 3 ml bupivacaine 0.5% + 120 international unit (IU) of hyaluronidase 50 mg magnesium sulphate 10 ml syringe (total volume injected 7 ml) over 10 minutes Single-injection percutaneous peribulbar block: After adequate sterilization, all patients received single-injection percutaneous peribulbar block by an experienced anesthesiologist. A 25G beveled 16mm needle was inserted 5mm below the inferior lacrimal punctum along the lower orbital margin, then advanced vertically till half its length then obliquely towards the optic foramen. After gentle negative aspiration, 7ml of the local anesthetic mixture was injected slowly and smoothly. The needle was afterwards gently retracted and gentle digital pressure applied intermittently to facilitate diffusion of the local anesthetic. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• ASA physical status I, II AND III. • Type of surgeries: Phacoemulsification surgeries for cataract extraction. • Axial length of the globe (AXL) < 30 mm. • ASA physical status IV & V. • Axial length (AXL) of the globe >30 mm. • Patients with contraindications to the block (with bleeding tendencies or on anticoagulant drugs, with infection at the site of injection or allergies to the test drugs). • Patients who could not lie flat for long periods of time. • Patients with tremors or agitation. • Patients with communication difficulties such as mental retardation, deafness, or disturbed conscious level. • Patients with single-seeing eye. • Prolonged or complicated surgeries duration > 3 hours. • Patients refusing to be included in the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 04/03/2018 Research Ethics committee faculty of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To prove that adding dexmedetomidine or magnesium sulphate to the anesthetic mixture in peribulbar block will enhance the quality & the duration of the peribulbar block . 5min, 10min, 15min, 30 min, 45 min, 60 min, 120 min
Secondary Outcome to compare between the effects of dexmedetomidine versus magnesium sulphate as an adjuvants to single-injection peribulbar anesthesia as a secondary goal. 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 120 min.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals. Elkalefa Elmamoon - Abbasiya - Cairo - Ain Shams University Hospitals Cairo 11588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aya Abuelyossr 4035 Zahraa Nasr city Cairo 11528 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Maha Sadek El Derh Department of anesthesia, Faculty of medicine, Ain Shams University. 34 Abbassieya Square. Cairo 1181 Egypt
Mai Mohsen Abdelaziz Department of anesthesia, Faculty of medicine, Ain Shams University. 34 Abbassieya Square. Cairo 1181 Egypt
Khaled Mohammed Maghawry Department of anesthesia, Faculty of medicine, Ain Shams University. 34 Abbassieya Square. Cairo 1181 Egypt
Naglaa Mohamed Aly Department of anesthesia, Faculty of medicine, Ain Shams University. 34 Abbassiya Square. Cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Abuelyossr ayaabuelyossr@med.asu.edu.eg 00201004518067 4035 Zahraa Nasr City
City Postal code Country Position/Affiliation
Cairo 11528 Egypt teaching assistant at department of anesthesia faculty of medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Khaled Maghawry Khaled_maghawry@med.asu.edu.eg 00201005180470 38 Abbassiya Square
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Professor of Anesthesiology
Role Name Email Phone Street address
Public Enquiries Maha El Derh mahaelderh@med.asu.edu.eg 00201144866675 34 Abbassiya square
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Lecturer of anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be available upon request from corresponding authors after approval by the sponsors and the study supervisors Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years from the end of the study Anesthesiologists and ophthalmologists
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