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Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

S

Selcuk University

Status

Completed

Conditions

Geriatrics
Outpatients
Personal Satisfaction

Treatments

Drug: Dexmedetomidine infusion
Drug: Remifentanil infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04935541
HEK 09/59-19

Details and patient eligibility

About

Dexmedetomidine is an α2-adrenergic receptor agonist used for its sympatholytic effect, providing sedation, analgesia, and cardiovascular stabilization in the perioperative period. Remifentanil is a µ opioid agonist with a rapid onset and short duration of action, which is degraded by plasma esterase in tissues. Investigators aimed to compare the effects of dexmedetomidine and remifentanil infusions on sedation quality, side effects, and surgeon's satisfaction in geriatric outpatients who underwent cataract surgery.

Full description

Dexmedetomidine is an α2 agonist and remifentanil is a short-acting μ, opioid agonist. The aim of this study was to compare dexmedetomidine and remifentanil infusions used for conscious sedation in geriatric patients undergoing outpatient cataract surgery in terms of sedation quality, hemodynamic stability, and surgeon satisfaction.

Eighty patients were divided into two groups according to the administration of dexmedetomidine (Group D) and remifentanil (Group R) infusion in this randomized, prospective, double-blinded study. In group D (n = 40), after a loading of 1 µg/kg dexmedetomidine in 10 minutes, 0.4 µg/kg/h-1 infusion was administered. In Group R (n = 40), remifentanil at a dose of 0.05 µg/kg-1 was administered for 10 minutes, and then 0.05 µg/kg/min-1 infusion was continued.

Enrollment

80 patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients between the ages of 65-80,
  • Who will undergo cataract surgery,
  • With the American Society of Anesthesiologists (ASA) score I-III.

Exclusion criteria

  • Second or third-degree heart block,
  • Chronic α2-agonist use,
  • Inability to communicate with the patient,
  • Uncontrolled systemic disease,
  • Allergy to local anesthetics,
  • Chronic analgesic or sedative drug use,
  • History of alcohol or substance addiction.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Dexmedetomidine infusion
Active Comparator group
Description:
Dexmedetomidine (Precedex, Meditera, USA) was administered at a loading dose of 1 µg/kg for 10 minutes before local anesthesia to be applied to the eye by the surgeon. During the surgical procedure, it was administered at a dose of 0.4 µg/kg/h-1 infusion.
Treatment:
Drug: Dexmedetomidine infusion
Remifentanil infusion
Active Comparator group
Description:
Remifentanil (Ultiva, Glaxo SmithKline, Turkey) infusion was started at a dose of 0.05 µg/kg/min-1, 10 minutes before the start of the surgery as baseline infusion and continued at the same infusion dose throughout the surgical procedure.
Treatment:
Drug: Remifentanil infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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