Remifentanil and Remimazolam to Limit Patient Movement

NCT ID: NCT06583811

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-01-10

Brief Summary

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.

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.

Conditions

Long-Eye Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

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

Interventions

Remifentanil

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

Intervention Type: DRUG

Other Intervention Names

emimazolam

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: collaborator

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Al-Azhar University hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M. Elnagar, M.D

Role: CONTACT

Ahmed.elnaggar@azhar.edu.eg

+201007529357

Other Identifiers

Remifentanil and Remimazolam

Identifier Type: -

Identifier Source: org_study_id