Viewing Study NCT04668456



Ignite Creation Date: 2024-05-06 @ 3:32 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04668456
Status: UNKNOWN
Last Update Posted: 2021-02-25
First Post: 2020-12-02

Brief Title: Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
Sponsor: Menoufia University
Organization: Menoufia University

Study Overview

Official Title: The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery A Comparative Randomized Controlled Double Blind Study
Status: UNKNOWN
Status Verified Date: 2021-02
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed 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-Tenons 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None