Remifentanil and Remimazolam to Limit Patient Movement
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2024
CompletedFirst Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2025
CompletedSeptember 4, 2024
July 1, 2024
6 months
August 30, 2024
August 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Eye Movement
Incidence of patients who are not moving their Eyes during long eye surgery
from 0 hours to 4 hours after the procedure
Study Arms (2)
Group A: Remifentanil Group
ACTIVE COMPARATORAbout 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 B: Remimazolam Group
ACTIVE COMPARATORAbout 35 Patients will receive remimazolam bolus of 0.2mg/kg followed by a continuous infusion of 0.3-0.5 μg/kg/h.
Interventions
to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egymedicalpedialead
- Al-Azhar Universitycollaborator
Study Sites (1)
Al-Azhar University hospitals
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 4, 2024
Study Start
July 10, 2024
Primary Completion
January 1, 2025
Study Completion
January 10, 2025
Last Updated
September 4, 2024
Record last verified: 2024-07