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CompletedNCT05215158Updated Nov 15, 2023

Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

An interventional study of Dexmedetomidine in Squint, sponsored by Aswan University Hospital. Completed at 2 sites in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Squint

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03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient planned to perform a unilateral strabismus surgery
  2. Age: 20-60 years
  3. class I and II

Exclusion criteria

Exclusion Criteria:

  1. patients under the age of 20
  2. uncooperative patients
  3. Patients with coagulopathy
  4. patients who disincline to participate in the study will be excluded from the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Peribulbar dexmedetomidine

    The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline containing 50 μg dexmedetomidine perineurally (30 patients).

    Drug: Dexmedetomidine

  • Active comparator
    Intravenous dexmedetomidine

    The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline. Patients received 50 μg dexmedetomidine in 50 mL of normal saline administered as an infusion over 10 minutes, and given 10 minutes before the peribulbar block (30 patients).

    Drug: Dexmedetomidine

Interventions

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

    Also known as: alpha-2 agonist

06

What researchers measure

Primary outcomes

  1. duration of analgesia

    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

    Time frame: 12 hours

07

Study locations

2 sites
  • Aswan University Hospital
    Aswan, 81511, Egypt
  • Huda Fahmy
    Aswan, 81511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05215158
Lead sponsor
Aswan University Hospital
Responsible party
Huda Fahmy Mahmoud, PhD (Assistant professor of Anesthesia and Intensive Care, Aswan University Hospital) — Principal investigator
First posted
Jan 31, 2022
Start date
Jan 28, 2022
Primary completion
Jul 1, 2023
Completion
Sep 15, 2023
Last update
Nov 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Dexmedetomidine

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