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OpenTrials
Completed

NCT Number: NCT05215158

Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital, Aswān, Egypt

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About this study

Strabismus (misalignment of the eye) results from a difference in extraocular muscle function. Consequently, two different images, one from each eye, are transmitted to the brain, resulting in a loss of visual depth. In adults, cosmetic appearance is the main issue but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the overlapping images. The goal of strabismus surgery is to align the eyes, reduce diplopia, and restore binocular vision Ophthalmic regional block can be used as the primary anesthetic technique for strabismus surgery. The advantages of ophthalmic regional blockade include a reduced incidence of oculocardiac reflex (OCR) and emergence agitation, postoperative analgesia, and decreased postoperative nausea and vomiting (PONV).

Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block.

Perineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia. Intravenous (I.V.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong sensory and motor blockade in addition to sedation and postoperative analgesia.

No previous studies where different routes of dexmedetomidine have been compared in adult strabismus surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient planned to perform a unilateral strabismus surgery
  • Age: 20-60 years
  • American Society of Anesthesiologists class I and II

Exclusion criteria

  • patients under the age of 20
  • uncooperative patients
  • Patients with coagulopathy
  • patients who disincline to participate in the study will be excluded from the study

Treatment and study plan

Dexmedetomidine

Drug

to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.

Other names: alpha-2 agonist

Primary outcomes

  1. duration of analgesia

    Time frame: 12 hours

    The time gap between the abolition of the sensation using gauze soaked in cooled normal saline, or corneal reflex, and the first postoperative demand for analgesia

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

A Comparative Study of Intravenous Versus Peribulbar Administration of Dexmedetomidine for Strabismus Surgery in Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2022
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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