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Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study

Primary Purpose

Benign Prostate Hyperplasia, Bladder Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Benign Prostate Hyperplasia focused on measuring dexmedetomidine, sedation in elderly patient, spinal anesthesia

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Elderly patients aged 65~85 years olds undergoing TURB or TURP.
  • No contraindication of spinal anesthesia.
  • ASA class I and II.
  • Patients consented to spinal anesthesia were enrolled.

Exclusion Criteria:

  • Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias, and patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study.

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group C

Group F

Arm Description

: Spinal anesthesia with 6mg bupivacaine and intrathecal placebo(normal saline) added

: Spinal anesthesia with 6mg bupivacaine and intrathecal small dose of fentanyl(20micro gram)

Outcomes

Primary Outcome Measures

Observer's Assessment of Alertness/Sedation scale, OAA/S
Observer's Assessment of Alertness/Sedation scale, OAA/S 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful trapezius squeeze 0 No response after painful trapezius squeeze 0 No response after painful trapezius squeeze

Secondary Outcome Measures

Full Information

First Posted
July 31, 2012
Last Updated
July 24, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01665586
Brief Title
Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently many studies reported that intraoperative dexmedetomidine administration undergoing spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not got general consensus. The investigators hypothesized that the dose requirements would be lower than in elderly patients than young patients. Furthermore, intrathecal small dose opioids enhance the analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of dexmedetomidine. The purpose of this study was to determine the dose of dexmedetomidine to provide satisfactory sedation undergoing spinal anesthesia with or without additive small dose intrathecal opioids. Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5, 0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient according to an up and down method. Intraoperative arterial pressure, heart rate, and bispectral index was compared. Postoperative pain score, the time for the regression of sensory and motor was recorded for further analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia, Bladder Tumor
Keywords
dexmedetomidine, sedation in elderly patient, spinal anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
: Spinal anesthesia with 6mg bupivacaine and intrathecal placebo(normal saline) added
Arm Title
Group F
Arm Type
Active Comparator
Arm Description
: Spinal anesthesia with 6mg bupivacaine and intrathecal small dose of fentanyl(20micro gram)
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
Spinal anesthesia regimen Group F: 6mg bupivacaine + 20mcg fentanyl (intrathecal) + o.4 cc 5% dextrose water Group C: 6mg bupivacaine + 0.4 cc normal saline + 0.4cc 5% dextrose water dexmedetomidine 0.2~0.8 micro gram/kg intravenous administration after the sterilization of the spinal anesthesia level, and prehydration
Primary Outcome Measure Information:
Title
Observer's Assessment of Alertness/Sedation scale, OAA/S
Description
Observer's Assessment of Alertness/Sedation scale, OAA/S 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful trapezius squeeze 0 No response after painful trapezius squeeze 0 No response after painful trapezius squeeze
Time Frame
from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly patients aged 65~85 years olds undergoing TURB or TURP. No contraindication of spinal anesthesia. ASA class I and II. Patients consented to spinal anesthesia were enrolled. Exclusion Criteria: Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias, and patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study.
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25971886
Citation
Kim J, Kim WO, Kim HB, Kil HK. Adequate sedation with single-dose dexmedetomidine in patients undergoing transurethral resection of the prostate with spinal anaesthesia: a dose-response study by age group. BMC Anesthesiol. 2015 Jan 27;15:17. doi: 10.1186/1471-2253-15-17.
Results Reference
derived

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Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study

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