Remifentanil and Remimazolam to Limit Patient Movement

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

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.

Study Overview

• Status: Recruiting
• Conditions: Long-Eye Surgeries
• Intervention / Treatment: Drug: Remifentanil

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M. Elnagar, M.D; Phone Number: +201007529357; Email: Ahmed.elnaggar@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al-Azhar University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Remifentanil Group; About 35 Patients will receive Remifentanil bolus of 1 μg/kg over 30 seconds followed by a continuous infusion of 0.03-0.05 μg/kg/min.	Drug: Remifentanil; to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.; Other Names: emimazolam
Active Comparator: Group B: Remimazolam Group; About 35 Patients will receive remimazolam bolus of 0.2mg/kg followed by a continuous infusion of 0.3-0.5 μg/kg/h.	Drug: Remifentanil; to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.; Other Names: emimazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye Movement	Incidence of patients who are not moving their Eyes during long eye surgery	from 0 hours to 4 hours after the procedure

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Collaborators: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 31, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: Remifentanil and Remimazolam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No