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Comparing Benzodiazepine-Ketamine and Benzodiazepine-Fentanyl sedation in Cataract surgery

Comparison between Benzodiazepine associated with Ketamine versus Benzodiazepine associated with Fentanyl in Phacoemulsification

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7c4c5jx
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

This is a randomized, controlled, double-blind clinical trial with two arms. At least forty-eight individuals meeting the eligibility criteria will be randomly allocated to receive two different inter

Sponsors

Hospital Oftalmológico de Brasília
Lead Sponsor
Hospital Oftalmológico de Brasília
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing phacoemulsification at HOBrasil, Salvador, Bahia; at least 18 years old; of both genders

Exclusion criteria

Exclusion criteria: Patients under 18 years of age; pregnant patients; patients with chronic pain syndrome; patients with hypersensitivity to any of the tested medications or the topical anesthesia used; patients with communication difficulties (significant hearing loss, speech impairments, aphasias); patients with physical status determined by the American Society of Anesthesiologists classification of III-VI

Design outcomes

Primary

MeasureTime frame
To determine whether ketamine combined with a benzodiazepine mitigates patient pain and maintains an adequate level of consciousness for performing phacoemulsification, in a manner not inferior to fentanyl combined with a benzodiazepine.

Secondary

MeasureTime frame
Analyze the adverse effects caused by the use of each sedative (ketamine combined with a benzodiazepine and fentanyl combined with a benzodiazepine).;Determine patient satisfaction with the use of each sedative using a Likert scale (1-5).;Determine the pain experienced by the patient with the use of each sedative using a Likert scale (1-5).;Determine the surgeon's satisfaction with the use of each sedative using the SURG-TLX questionnaire.

Countries

Brazil

Contacts

Public ContactAdriano Faneli

Instituto de Olhos Freitas

adrianofaneli@gmail.com+55-71-33306100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)