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.: PACTR201608001659287 Date of Approval: 02/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Between Dexmedetomidine and Fentanyl As An Adjuvant With Ropivacaine in Peribulbar Block For cataract Surgery
Official scientific title Comparison Between Dexmedetomidine and Fentanyl As An Adjuvant With Ropivacaine in Peribulbar Block For cataract Surgery
Brief summary describing the background and objectives of the trial The great majority of patients undergoing cataract surgery are elderly who have several co-morbidities, so regional anesthesia is the preferred one. Because of its safety, ease to perform and its efficacy, the peribulbar is the most common anesthesia used for Cataract surgery (1). When local anesthetics used alone for peribulbar block, there is may be delayed akinisia and delayed corneal anesthesia and frequent need for block supplementation (2, 3). So several adjuvant can be used with to improve the quality of peribulbar block as hyaluronidase (4), sodium bicarbonate (5), clonidine (6), neuromuscular blocking agents (7, 8) and fentanyl (9). Dexmedetomidine is highly selective ¿2-adrenergic agonist more potent and faster acting than clonidine (10). It has analgesic, sedative, antihypertensive, and anesthetic sparing effects (11). Dexmedetomidine has been used as adjuvant to local anesthetics in regional anesthesia (12, 13). So the aim of the study to evaluate and compare the effects of dexmedetomidine and fentanyl as an adjuvant to ropivacaine on the quality of the peribulbar block as well as their sedative effect.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cataract surgery,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/01/2015
Actual trial start date 16/05/2015
Anticipated date of last follow up 01/08/2016
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 randomisation using a randomisation 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
Control Group control group peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1 ml of normal saline throughout the surgical time ): patients will receive peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1 ml of normal saline. 30 Placebo
Experimental Group Dexmedetomidine group peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase (Hyalase® 1500 IU, Wockhardt, UK) and 1 ml of 50 ¿g of dexmedetomidine (50 ¿g in 0.5-ml saline) throughout the surgical time patients will receive peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase (Hyalase® 1500 IU, Wockhardt, UK) and 1 ml of 50 ¿g of dexmedetomidine (50 ¿g in 0.5-ml saline). 30
Experimental Group Fentanyl group peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1 ml of 25 ¿g of fentanyl (25 ¿g in 0.5-ml saline throughout the surgical time patients will receive peribulbar anesthesia using a mixture of 6 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1 ml of 25 ¿g of fentanyl (25 ¿g in 0.5-ml saline). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients American Society of Anesthesiologists (ASA) physical status I and III patients scheduled to undergo cataract extraction surgery Patients with a history of allergy to local anesthetics, severe systemic disease, active ocular infection, single eye, who were pregnant, coagulopathy or those taking anti-coagulants, anti-epileptic drugs, anti-psychotic medication, anti-glaucoma drugs, atrioventricular block, chronic clonidine therapy, and obstructive apnea 18 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 16/05/2016 Tanta University, Faculty of medicine, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish Tanta 31512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time for adequate conditions to start the surgery before blocking, then 3, 5, and 10 minutes after the block
Primary Outcome sedation levels will be assessed with Ramsy sedation scale at every 10 minutes during surgery and every 30 minutes in first 2 hours
Primary Outcome duration sensory and motor block at the end of surgery and every hour up to 2 h and then at 6 h and 8h
Secondary Outcome postoperative pain at the end of surgery and every hour up to 2 h and then at 6 h and 8 h
Secondary Outcome total analgesic requirement within 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals algeish Tanta 31512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source for funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine, tanta university tanta, methabash Tanta 31512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona M Mogahid Algeish Tanta 31512 Egypt
Mohamed M Abu Elyazed Algeish Tanta 31512 Egypt
Mohamed S Abdghafear algeish Tanta 31512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed AbdElghafear mohamedghafar76@yahoo.com 00201005406231 algeish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Public Enquiries Mohamed AbuElyazed mohd_yazed75@yahoo.com +20403462350 algheish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbdElghafear mohamedghafar76@yahoo.com 00201005406231 algeish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
REPORTING
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