Dexmedetomidine Adjuvant in Retinal Surgery
DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY
1 other identifier
interventional
90
1 country
1
Brief Summary
During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration and unexpected globe movement .so many adjuvant was added to LA to overcome this disadvantages of LA such as clonidine and fentanyl . The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 31, 2015
March 1, 2015
1 year
October 31, 2014
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
onset, duration of the motor and sensory block
A block was considered satisfactory when complete akinesia occurred. In the absence of complete akinesia in any direction after 10 min, supplementary anesthesia given by a further injection of 2-4 ml of the test solution in the same manner as given before. Calculate the number of patients needed supplemental block were. The surgeon assessed the duration of surgery anesthesia and akinesia. Intraocular pressure measured before block, immediately after block and before surgical procedures
10 minutes from injection
Secondary Outcomes (1)
observe the adverse effects of Dexmedetomidine
during and after surgery
Study Arms (2)
5 micron dex arm
EXPERIMENTAL10 micron dex arm
EXPERIMENTALInterventions
Does adding 5 or 10 micron of DEXMEDETOMIDINE to peribulbar anesthesia is any different from regular peribulbar anesthesia practice?
Eligibility Criteria
You may qualify if:
- Adult patients
- Going for elective vitreoretinal surgery.
You may not qualify if:
- History of coagulation abnormalities.
- Allergy to local anesthetics.
- Cardiac, hepatic or renal failure,
- Chronic clonidine or analgesic therapy.
- One-eyed patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdulaziz University Hospital at King Saud University
Riyadh, Riyadh Region, 11411, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marwan Abouammoh, MD
King Saud University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 4, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
May 1, 2015
Last Updated
March 31, 2015
Record last verified: 2015-03