Peribulbar Anesthesia Clinical Trial
Official title:
DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY
| Verified date | March 2015 |
| Source | King Saud University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Saudi Arabia: Ministry for Higher Education |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 90 |
| Est. completion date | May 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Adult patients - Going for elective vitreoretinal surgery. Exclusion Criteria: - History of coagulation abnormalities. - Allergy to local anesthetics. - Cardiac, hepatic or renal failure, - Chronic clonidine or analgesic therapy. - One-eyed patients |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | King Abdulaziz University Hospital at King Saud University | Riyadh |
| Lead Sponsor | Collaborator |
|---|---|
| King Saud University |
Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. |
during and after surgery | Yes |