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The goal of this prospective, randomized, single-blinded is to learn if there is an ideal sedation protocol in cataract surgery in adults.
The main questions it aims to answer are:
Researchers will compare 3 sedation protocols : Dexmedetomidine versus Propofol versus the combination of these 2 drugs and to see if one protocol is overall superior to the others. Fentanyl will also be used in all 3 sedation protocols.
Participants will :
Cataract surgery is one of the most frequently performed procedures worldwide, particularly among elderly patients with multiple comorbidities. Although typically performed under regional or topical anesthesia, procedural sedation is often necessary to ensure patient comfort and immobility. The ideal sedative agent should offer adequate anxiolysis and analgesia with minimal cardiorespiratory depression and prompt recovery. Both dexmedetomidine and propofol are commonly used for procedural sedation; however, their comparative efficacy when combined with fentanyl and combined together in cataract surgery remains unclear. This study compares the efficacy, safety, and patient satisfaction between dexmedetomidine-fentanyl, propofol-fentanyl, and dexmedetomidine-propofol-fentanyl sedation.
In this prospective, randomized, single-blind study, patients undergoing elective cataract surgery were allocated to three groups:
Every patient is assigned randomly to a group. 3 different anesthesiologists will administer the protocol. The Ramsay score will be evaluated by the anesthesiologists themselves and a trained CRNA during the surgery and in the recovery room. The Ramsay score is explained in detail to the Anesthesiologist and CRNA in charge, with practical examples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine-fentanyl DEX-FEN | Active Comparator | DEX-FEN group: received dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h) and a single fentanyl bolus (1 µg/kg). |
|
| Propofol-Fentanyl PRO-FEN | Active Comparator | PRO-FEN group: received propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible) and a single fentanyl bolus (1 µg/kg). |
|
| DEX-PRO-FEN | Active Comparator | DEX-PRO-FEN : received dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h), propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible), with a single fentanyl bolus (1 µg/kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine (DEX) | Drug | Dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ramsay sedation scale during surgery | The Ramsay Sedation Scale (RSS) is a 6-point tool used in medicine to assess a patient's level of sedation, from agitated (1) to deeply comatose (6), by evaluating their responsiveness to stimuli like voice and touch, helping clinicians achieve desired sedation levels. | through study completion, an average of 1 year |
| Ramsay sedation scale in the recovery room | The Ramsay Sedation Scale (RSS) is a 6-point tool used in medicine to assess a patient's level of sedation, from agitated (1) to deeply comatose (6), by evaluating their responsiveness to stimuli like voice and touch, helping clinicians achieve desired sedation levels. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rhea Nacouzi, MD | Contact | +961 3359528 | rhea.nacouzi@net.usj.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Naji Abou Jalad, MD | Hotel Dieu de France Hospital, Beirut, Lebanon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel-Dieu de France | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol (PRO) | Drug | Propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible). |
|
| Fentanyl (FEN) | Drug | Single fentanyl bolus (1 µg/kg). |
|
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |