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Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries

Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07671066
Enrollment
75
Registered
2026-06-26
Start date
2024-12-01
Completion date
2026-01-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Surgeries, Dexamethasone, Dexmedetomidine, Local Anesthetic, Peribulbar Block

Brief summary

This study aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery.

Detailed description

Regional block (especially peribulbar block) is the preferred choice of anesthesia for many ophthalmic surgeries as it has less complications. Peribulbar block with local anesthetics only lead to delayed onset corneal anesthesia and globe akinesia, and frequent need of block supplementation. Dexmedetomidine is a drug which belongs to alpha 2 adrenergic receptor agonist. It provides several desirable effects, including sedation, anxiolysis, analgesia, and a reduction in intraoperative opioid requirements, when used as an adjuvant to local anesthetics, dexmedetomidine has been shown to prolong the duration of sensory and motor blocks, improve hemodynamic stability, and enhance overall patient satisfaction. Dexamethasone, a synthetic corticosteroid, the use of dexamethasone as an additive in peribulbar blocks has been shown to improve the quality of anesthesia, reduce the need for supplemental intraoperative analgesics, and decrease postoperative pain.

Interventions

DRUGDexmedetomidine

Patients received 20 μg of dexmedetomidine in 1 ml solution.

DRUGDexamethasone

Patients received 4 mg dexamethasone in 1 ml solution.

DRUGNormal saline

Patients received 1 ml normal saline.

Sponsors

Helwan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age: \> 18 years old. * Sex: Male \& Female * American Society of Anesthesiologists (ASA) Physical status I -III. * Patients undergoing ophthalmic surgery under local anesthesia.

Exclusion criteria

* Patients' refusal. * Patients have active ocular infection. * Patients have single eyes. * Allergy to thesis medications (mainly bupivacaine and lidocaine). * Patients cannot lie flat. * Patient on anticoagulation. * Abnormal coagulation profile in the form of international normalized ratio (INR) ≥1.6

Design outcomes

Primary

MeasureTime frameDescription
Time for first request of the rescue analgesia24 hours postoperativelyTime for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.

Secondary

MeasureTime frameDescription
Postoperative opioid consumption12 hours postoperativelyIf the Visual analogue score (VAS) was \>4, a 0.1 mg/kg bolus dose of intravenous morphine will be administered if no response the bolus dose will be repeated with a maximum dose of 10 mg.
Degree of patient satisfaction24 hours postoperativelyDegree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
Degree of pain12 hours postoperativelyEach patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded , 2, 4, 8, and 12 hours postoperatively.
Heart rate12 hours postoperativelyHeart rate was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.
Mean arterial blood pressure12 hours postoperativelyMean arterial blood pressure was measured before and after the peribulbar injection (baseline) (5,10, 15, 30, 45, 60, 90 till 120 min) the each 6 hours for 12 hours postoperatively.
Intraocular pressure10 min after injection of local anestheticsIntraocular pressure (IOP) was measured 30 min before injection of the local anesthetics as a baseline reading. The other reading 10 min after injection of local anesthetics.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026