Dexmedetomidine Adjuvant in Retinal Surgery

Phase 3

• Conditions: Peribulbar Anesthesia
• Interventions: Drug: DEXMEDETOMIDINE

• Registration Number: NCT02282787
• Lead Sponsor: King Saud University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 micron dex arm	DEXMEDETOMIDINE	-
5 micron dex arm	DEXMEDETOMIDINE	-

Primary Outcome Measures

Name	Time	Method
onset, duration of the motor and sensory block	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

Secondary Outcome Measures

Name	Time	Method
observe the adverse effects of Dexmedetomidine	during and after surgery	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.

Trial Locations

Locations (1)

King Abdulaziz University Hospital at King Saud University; 🇸🇦 Riyadh, Saudi Arabia