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.: PACTR201603001485381 Date of Approval: 23/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ophthalmic Anesthesia and analgesia
Official scientific title Effect of use of dexmedetomidine as adjuvant in single injection percutanous peribulbar anesthesia in patients presented for vitroretinal surgeries
Brief summary describing the background and objectives of the trial Dexmedetomidine is an alpha 2 receptor agonist drug that had been recently introduced into medical practice. It have sedative, hypnotic, and potent analgesic action and used mainly as sedative agent in critically ill patients. However, its use as adjuvant to local anesthetics in regional and local anesthesia techniques have been widely studied as it is thought that its use is associated with faster onset, improved sensory and motor block, and improved patients satisfaction. Patients with vitroretinal disorders presented for surgeries usually suffer from multiple medical co-morbidities that may increase risk of general anesthesia. Regional anesthesia is good alternative to general anesthesia in high risk medical patients. Single injection percutanous peribulbar block using short needles is a popular choice in such patients. However, vitroretinal surgeries are lengthy procedures that require more prolonged duration of sensory and motor block which may be not reached by use of classical local anesthetic drugs. The use of additives to local anesthetics may be associated with improved sensory and motor block. Dexmedetomidine is thought to be good adjuvant to local anesthetics in peribulbar block. The aim of this study is evaluation of effect of adding dexmedetomidine to local anesthetics in peribulbar block. This study will include 60 adult patients admitted to Tanta University Hospital and scheduled for vitroretinal surgery. The patients will be randomly classified into two equal groups. In group I, patients will receive peribulbar block with use of local anesthetics alone, while, in group II, patients will receive peribulbar block with local anesthetics added to dexmedetomidine. Our measurements will include, onset and duration of sensory and motor block, level of sedation, haemodynamic parameters, and incidence of complication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/01/2016
Actual trial start date 02/02/2016
Anticipated date of last follow up 02/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 73
Recruitment status Completed
Publication URL https://www.sciencedirect.com/science/article/pii/S1110184917303264
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline group 2 ml of 0.9% normal saline single injection Percutanous peribulbar block 30 Uncontrolled
Experimental Group Dexmedetomidine group 20 ug dissolved in 1 ml single use Percutanous peribulbar block 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA class I- III Aged 30- 60 years old Scheduled for vitreoretinal surgeries Patients refusal Patients with glaucoma or ocular infection Patients with impaired orbital sensation Patients with suspected or known coagulopathy Patients with recent myocardial or cerebral events Patients with mental retardation 30 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 28/01/2016 Research ethics committee, Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Al geish Tanta 31471 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of globe akinesia Before procedure Every 1 minute in first 5 minutes after procedure Every 15 minutes in the next 1 hour Every 1 hour till 8 hours
Secondary Outcome Onset and duration of anesthesia Before the block, then, every 10 minutes till end of surgery, then every 1 hour till 8 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals Al geish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospitals Al geish st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Tanta University Hospital Algeish st Tanta, Gharbya 31741 Egypt Hospital
Primary Sponsor Tanta University Hospital Al geish st Tanta, Gharbya 31741 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sameh Abdelkhalik Ahmed Ismaiel Saied st Tanta, Gharbya 31741 Egypt
Muhamed Gamal Almawy Al nady st Tanta, Gharbya 31741 Egypt
Amr Ahmed Magdy Abdelfattah Ghouraba st Tanta, Gharbya 31741 Egypt
Mohammed Samir Abdelghafar Ali st Tanta 31511 Egypt
Mohamed Abdelhamid Nassif Stadium Street Tanta 31511
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@Gmail.com 00201002977048 Saied st
City Postal code Country Position/Affiliation
Tanta, Gharbya 31741 Egypt Lecturer at Tanta University
Role Name Email Phone Street address
Public Enquiries Mohamed Elshazly moshhansaky@Gmail.com 00201226896829 Al Galaa
City Postal code Country Position/Affiliation
Tanta, Gharbya 31741 Egypt Head of funding resources of magrabi eye hospital Tanta
Role Name Email Phone Street address
Scientific Enquiries Salah Alsherif Salahalsherif505@yahoo.com 00201020150330 In elfared st
City Postal code Country Position/Affiliation
Tanta, Gharbya 31741 Egypt Professor of Anesthesiology and surgical intensive Care- Tanta University
REPORTING
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