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NCT Number: NCT04935541

Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

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.

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Key information

Conditions

Geriatrics Behavior Cataract Eye Diseases Lens Diseases Outpatients Personal Satisfaction

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine infusion

Drug

After Dexmedetomidine infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Other names: Cataract surgery

Remifentanil infusion

Drug

After Remifentanil infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Other names: Cataract surgery

Primary outcomes

  1. Sedation quality

    Time frame: 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.

  2. Sedation level

    Time frame: 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.

  3. Pain intensity

    Time frame: 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.

Secondary outcomes

  1. Side effects

    Time frame: 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.

  2. Surgeon's satisfaction

    Time frame: 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.

  3. Pain intensity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

The Comparison of Dexmedetomidine and Remifentanil Infusion in Geriatric Patients Undergoing Outpatient Cataract Surgery: A Prospective, Randomized, Blinded Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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