Peribulbar AnesthesiaPhase 3NCT02282787
Dexmedetomidine Adjuvant in Retinal Surgery
A Phase 3 study testing DEXMEDETOMIDINE in people with Peribulbar Anesthesia, run by King Saud University at 1 site in Saudi Arabia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peribulbar Anesthesia
- What is being tested?
- DEXMEDETOMIDINE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2014to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Going for elective vitreoretinal surgery.
Who cannot join
- History of coagulation abnormalities.
- Allergy to local anesthetics.
- Cardiac, hepatic or renal failure,
- Chronic clonidine or analgesic therapy.
- One-eyed patients
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University Hospital at King Saud University
Riyadh, Riyadh Region, 11411
About this study
Official title: DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY
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
- Conditions
- Peribulbar Anesthesia
- Being tested
- DEXMEDETOMIDINE
- Keywords
- local anesthesia, peribulbar anesthesia, DEXMEDETOMIDINE, vitreoretinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXMEDETOMIDINEDrug
Does adding 5 or 10 micron of DEXMEDETOMIDINE to peribulbar anesthesia is any different from regular peribulbar anesthesia practice?
| Study group | Role | What they receive |
|---|---|---|
| 5 micron dex arm | Experimental | Not described Receives: Drug: DEXMEDETOMIDINE |
| 10 micron dex arm | Experimental | Not described Receives: Drug: DEXMEDETOMIDINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes from injection
Secondary outcomes (1)
observe the adverse effects of Dexmedetomidine
ECG, invasive BP and pulse oximetry will apply to all patients.
- The haemodynamic parameters (MAP and HR) will be continuously measured, and will be recorded at before induction (baseline), one minute after block . after 5 minutes then at the surgical incision, 15-min intervals intraoperatively, the end of surgery and10 and 20 minutes postoperatively.
Incidence of Oculocardiac reflex (OCR) or any arrhythmia during surgery.
Measured: during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peribulbar AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Abouammoh, King Saud University
- Investigators
- Marwan Abouammoh, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282787
- Sponsor's protocol ID
- E-14-1291
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY
- ClinicalTrials.gov ID
- NCT02282787
- Acronym / sponsor ID
- E-14-1291
- Conditions
- Peribulbar Anesthesia
- Keywords
- local anesthesia, peribulbar anesthesia, DEXMEDETOMIDINE, vitreoretinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (estimated)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 micron dex arm | Experimental | Drug: DEXMEDETOMIDINE |
| 10 micron dex arm | Experimental | Drug: DEXMEDETOMIDINE |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients
- Going for elective vitreoretinal surgery.
Key exclusion criteria (5 listed)
- History of coagulation abnormalities.
- Allergy to local anesthetics.
- Cardiac, hepatic or renal failure,
- Chronic clonidine or analgesic therapy.
- One-eyed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXMEDETOMIDINEDoes adding 5 or 10 micron of DEXMEDETOMIDINE to peribulbar anesthesia is any different from regular peribulbar anesthesia practice? | Drug | 10 micron dex arm, 5 micron dex arm |
Primary outcome
onset, duration of the motor and sensory block
Time frame: 10 minutes from injection
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
1 secondary outcome
observe the adverse effects of Dexmedetomidine
Time frame: during and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
Related trials for Peribulbar Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Abouammoh, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DEXMEDETOMIDINE in people with Peribulbar Anesthesia, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset, duration of the motor and sensory block (time frame: 10 minutes from injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015; AzTrials last refreshed its copy on 30 Oct 2026.