Geriatrics Clinical Trial
Official title:
The Comparison of Dexmedetomidine and Remifentanil Infusion in Geriatric Patients Undergoing Outpatient Cataract Surgery: A Prospective, Randomized, Blinded Study
NCT number | NCT04935541 |
Other study ID # | HEK 09/59-19 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2009 |
Est. completion date | July 2010 |
Verified date | June 2021 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 80 Years |
Eligibility | 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 a2-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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Sihhiye |
Lead Sponsor | Collaborator |
---|---|
Selcuk University | Hacettepe University |
Turkey,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sedation quality | 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. | Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit. | |
Primary | Sedation level | 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. | The time interval immediately after the surgery starts and immediately after the surgery ends. | |
Primary | Pain intensity | 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. | The time interval between the start of the surgery and the end of the surgery. | |
Secondary | Side effects | 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. | The time interval between the start and the end of the surgery. | |
Secondary | Surgeon's satisfaction | 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. | Immediately after the surgeon finishes the operation. | |
Secondary | Pain intensity | 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). | 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. |
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