Clinical trial NCT04935541: Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics
Official title: The Comparison of Dexmedetomidine and Remifentanil Infusion in Geriatric Patients Undergoing Outpatient Cataract Surgery: A Prospective, Randomized, Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatrics
Outpatients
Personal Satisfaction
Keywords: geriatrics
ambulatory surgery
cataract
anesthesia
conscious sedation
dexmedetomidine
remifentanil
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2021-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sedation quality
timeFrame: Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit.
measure: Sedation level
timeFrame: The time interval immediately after the surgery starts and immediately after the surgery ends.
measure: Pain intensity
timeFrame: The time interval between the start of the surgery and the end of the surgery.
Secondary outcomes:
measure: Side effects
timeFrame: The time interval between the start and the end of the surgery.
measure: Surgeon's satisfaction
timeFrame: Immediately after the surgeon finishes the operation.
measure: Pain intensity
timeFrame: Immediately after the surgical procedure is completed and the patient is transferred to the postoperative care unit and before the patient is transferred to the outpatient service.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Nalan Celebi, Professor
role: STUDY_CHAIR
References:
citation: Kumar CM, Seet E, Eke T, Irwin MG, Joshi GP. Peri-operative considerations for sedation-analgesia during cataract surgery: a narrative review. Anaesthesia. 2019 Dec;74(12):1601-1610. doi: 10.1111/anae.14845. Epub 2019 Sep 19.