Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Remifentanil infusion	Remifentanil infusion	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.
Dexmedetomidine infusion	Dexmedetomidine infusion	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.

Primary Outcome Measures

Name	Time	Method
Sedation level	The time interval immediately after the surgery starts and immediately after the surgery ends.	Bispectral Index (BIS) was used to determine the sedation level of each patient. The minimum and maximum values for BIS were between 0 and 100. Lower scores mean a deep sedation level.
Pain intensity	The time interval between the start of the surgery and the end of the surgery.	The Verbal Rating Scale was used to determine severity of the pain in the perioperative period. VRS is a 5-point scale including expressions defining the level of pain intensity (no pain, mild pain, moderate pain, intense pain and maximum pain). Higher scores mean intense pain.
Sedation quality	Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit.	The Observer Assessment Warning/Sedation Scale (OAA/S) was used to determine the sedation quality of each patient. The minimum and maximum values of OAA/S scale was between 0 and 5. Lower scores mean a better sedation quality.

Secondary Outcome Measures

Name	Time	Method
Surgeon's satisfaction	Immediately after the surgeon finishes the operation.	The surgeon's satisfaction in terms of the patient's sedation level, cooperation, and anesthesia management was evaluated using a questionnaire. The clinician satisfaction questionnaire was also classified as follows; 0: Not satisfied, 1: Less Satisfied, 2: Satisfied.
Side effects	The time interval between the start and the end of the surgery.	The Vissual Analogue Scale (VAS) was used to measure the frequency and severity of nausea and vomiting in the perioperative period. The VAS score is discovered by measuring the distance (mm) on the 100-mm line. Patients scoring 75 mm or more were considered to have clinically significant nausea and vomiting.
Pain intensity	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.	The Visual Analogue Scale (VAS) was used to determine the pain intensity in the postoperative period. The pain score is discovered by measuring the distance (mm) on the 100-mm line. Pain level was classified as follows; no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).