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NCT Number: NCT06583811

Remifentanil and Remimazolam to Limit Patient Movement

Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.

Sedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.

Recruiting

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Key information

Conditions

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University hospitals

Cairo, Egypt

Location status: Recruiting

About this study

Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization. Many ophthalmic procedures can be performed safely in an outpatient setting, using local anesthesia.

Propofol is currently the most commonly used intravenous anesthetic. It has a rapid onset of action, a short half-life and is associated with rapid recovery of cognitive ability. However, propofol can lead to injection pain, propofol infusion syndrome, and hemodynamic and respiratory depression. Therefore, there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia.

Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects. Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation.

Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A (GABA-A) receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body. Remimazolam is metabolized by a nonspecific esterase, and the metabolite has no pharmacological effect, which allows prolonged infusion without accumulation.

It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration, making it more suitable for use in elderly and hemodynamically unstable patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 40 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Undergoing long-eye surgeries under local anesthesia using peribulbar block with an expected surgical time of more than one hour.

Exclusion criteria

  • Patients on aspirin or anticoagulants.
  • Allergy to any study medication.
  • Drug abuse.
  • Uncontrolled hypertension.
  • Hyperthyroidism.
  • Frequent cough.
  • Impaired hearing.
  • Severe liver and kidney dysfunction.
  • Neurological or psychological disorders.
  • Partial or failed block.

Treatment and study plan

Remifentanil

Drug

to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.

Other names: emimazolam

Primary outcomes

  1. Eye Movement

    Time frame: from 0 hours to 4 hours after the procedure

    Incidence of patients who are not moving their Eyes during long eye surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M. Elnagar, M.D

CONTACT

[email protected]

+201007529357

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Collaborators

  • Al-Azhar University

Registry information

Official study title

Remifentanil and Remimazolam to Limit Patient Movement During Long-Eye Surgeries Under Local Anesthesia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

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.