Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

Menoufia University

Status and phase: Unknown; Phase 3

Conditions: Acute Postoperative Pain

Treatments: Drug: Normal saline; Drug: bupivacine 0.5%; Drug: Dexmedetomidine; Drug: lidocaine 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT04668456

8/8/2020 ANET4

Details and patient eligibility

About

The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.

Full description

Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.

The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.

Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.

Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA grade I-III
• Aged 18-70 years
• Both sex
• Scheduled for elective phacoemulsification cataract surgery

Exclusion criteria

• Coagulation abnormalities
• Impaired mental status
• Refusal of the patient
• Uncontrolled glaucoma
• Recent surgical procedure on the same eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Group C (control group)

Placebo Comparator group

Description:

Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Treatment:

Drug: bupivacine 0.5%

Drug: lidocaine 2%

Drug: Normal saline

Group SD (subtenon dexmedetomiine)

Active Comparator group

Description:

Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Treatment:

Drug: bupivacine 0.5%

Drug: Dexmedetomidine

Drug: lidocaine 2%

Drug: Normal saline

Group ID (iv dexmedetomidine)

Active Comparator group

Description:

Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.

Treatment:

Drug: bupivacine 0.5%

Drug: Dexmedetomidine

Drug: lidocaine 2%