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Completed

NCT Number: NCT07671066

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

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.

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Key information

Conditions

Dexmedetomidine Cataract Surgeries Dexamethasone Local Anesthetic Peribulbar Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, 11795, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexmedetomidine

Drug

Patients received 20 μg of dexmedetomidine in 1 ml solution.

Dexamethasone

Drug

Patients received 4 mg dexamethasone in 1 ml solution.

normal saline

Drug

Patients received 1 ml normal saline.

Primary outcomes

  1. Time for first request of the rescue analgesia

    Time frame: 24 hours postoperatively

    Time for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: 12 hours postoperatively

    If 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.

  2. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).

  3. Degree of pain

    Time frame: 12 hours postoperatively

    Each 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.

  4. Heart rate

    Time frame: 12 hours postoperatively

    Heart 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.

  5. Mean arterial blood pressure

    Time frame: 12 hours postoperatively

    Mean 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.

  6. Intraocular pressure

    Time frame: 10 min after injection of local anesthetics

    Intraocular 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.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

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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