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Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

Primary Purpose

Geriatrics, Outpatients, Personal Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dexmedetomidine infusion
Remifentanil infusion
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Geriatrics focused on measuring geriatrics, ambulatory surgery, cataract, anesthesia, conscious sedation, dexmedetomidine, remifentanil

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine infusion

Remifentanil infusion

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
June 7, 2021
Last Updated
June 22, 2021
Sponsor
Selcuk University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04935541
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatrics, Outpatients, Personal Satisfaction
Keywords
geriatrics, ambulatory surgery, cataract, anesthesia, conscious sedation, dexmedetomidine, remifentanil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The surgeon who performed the surgery, the participants included in the study, and the technician who collected the study data were unaware of the study groups and the type of drugs used for sedation.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine infusion
Arm Type
Active Comparator
Arm 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.
Arm Title
Remifentanil infusion
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Other Intervention Name(s)
Cataract surgery
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remifentanil infusion
Other Intervention Name(s)
Cataract surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sedation quality
Description
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 Frame
Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit.
Title
Sedation level
Description
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.
Time Frame
The time interval immediately after the surgery starts and immediately after the surgery ends.
Title
Pain intensity
Description
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.
Time Frame
The time interval between the start of the surgery and the end of the surgery.
Secondary Outcome Measure Information:
Title
Side effects
Description
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.
Time Frame
The time interval between the start and the end of the surgery.
Title
Surgeon's satisfaction
Description
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.
Time Frame
Immediately after the surgeon finishes the operation.
Title
Pain intensity
Description
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).
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.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients between the ages of 65-80 were enrolled in the study.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalan Celebi, Professor
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Sıhhiye
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We plan to share our patients' data and statistical analysis with individual researchers.
Citations:
PubMed Identifier
31535721
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.
Results Reference
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Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

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