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The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly

Primary Purpose

Benign Prostatic Hypertrophy

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

About this trial

This is an interventional supportive care trial for Benign Prostatic Hypertrophy

Eligibility Criteria

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

Inclusion Criteria:

  • ASA I-III
  • the patient who undergoing elective TURP for benign prostatic hypertrophy under spinal anesthesia

Exclusion Criteria:

  • Past history of spine surgery
  • infection focus at back
  • coagulopathy
  • hypersensitivity to local anaesthetics or DMT
  • mental disturbance
  • neurological disease

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DXM-bupivacaine

saline-bupivacaine

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of efficacy of DXM-bupivacaine
The primary objective is to evaluate the effects of DXM-bupivacaine in spinal block level compare to the saline-bupivacaine (peak sensory block level, time to peak sensory block level reached).

Secondary Outcome Measures

Comparison of the degree of the postoperative analgesic effect
Secondary objective is the comparison of the degree of the postoperative analgesic effect between the DXM group and the Saline group (visual analog scale at postoperative 6 hours and 24 hours, time to first analgesic request).

Full Information

First Posted
April 15, 2011
Last Updated
March 4, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01342562
Brief Title
The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (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
Spinal block is the most common anesthetic technique for transurethral resection of prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to limit the block level to minimize the hemodynamic changes. However, sometimes it may not provide an adequate level of sensory block. Thus, intrathecal additive is frequently administer with local anesthetic to improve analgesic effect. Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural space in humans without any reports of neurological deficits. Previous clinical studies showed that intravenous dexmedetomidine administration prolonged the sensory and motor blocks of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal DXM with local anesthesia in humans are scarce in the literature. Kanazi et al. found that 3μg DXM added to 12 mg spinal bupivacaine produced the significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than bupivacaine. And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant to 12.5mg bupivacaine in spinal anesthesia has a dose dependant effect on the onset and regression of sensory and motor block. In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic level when opioid was added with local anesthetic. However, opioid-induced side effects, such as pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this study is to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the effective spinal anesthesia and postoperative analgesia with minimal side effect compare to the local anesthetic only group. This study was conducted in a randomized, double-blind, controlled fashion. Patients were randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)-in total, bupivacaine 0.4% (1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg) in dextrose 8% solution + normal saline 0.3 ml -in total, bupivacaine 0.4% (1.5 ml) intrathecally. After spinal block, the level of sensory block, defined as the dermatomal segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold sensation to alcohol swab was measured every 2 min after intrathecal injection. The investigators recorded the peak sensory block level, time to peak block level from intrathecal injection, blood pressure and heart rate, and analgesic supplementation during operation. The maximum motor block level was assessed according to the modified Bromage scale. During postoperative period, the frequency of analgesic requirement, time to the first analgesic request, and pain scores were evaluated by blind investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DXM-bupivacaine
Arm Type
Experimental
Arm Title
saline-bupivacaine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
spinal anesthesia
Intervention Description
0.4% bupivacaine(normal saline 0.3ml with dexmedetomidine 3 mcg)
Intervention Type
Drug
Intervention Name(s)
spinal anesthesia
Intervention Description
0.4% bupivacaine(normal saline 0.3 ml with 0.5% bupivacaine 1.2 ml)
Primary Outcome Measure Information:
Title
Evaluation of efficacy of DXM-bupivacaine
Description
The primary objective is to evaluate the effects of DXM-bupivacaine in spinal block level compare to the saline-bupivacaine (peak sensory block level, time to peak sensory block level reached).
Time Frame
The sensory block level at every 2 minutes (up until 14 minutes) after drug injection during spinal anesthesia
Secondary Outcome Measure Information:
Title
Comparison of the degree of the postoperative analgesic effect
Description
Secondary objective is the comparison of the degree of the postoperative analgesic effect between the DXM group and the Saline group (visual analog scale at postoperative 6 hours and 24 hours, time to first analgesic request).
Time Frame
change in VAS(Visual Analog Scale) at 6 hours and 24 hours after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-III the patient who undergoing elective TURP for benign prostatic hypertrophy under spinal anesthesia Exclusion Criteria: Past history of spine surgery infection focus at back coagulopathy hypersensitivity to local anaesthetics or DMT mental disturbance neurological disease
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16430546
Citation
Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.
Results Reference
background
PubMed Identifier
20467879
Citation
Elcicek K, Tekin M, Kati I. The effects of intravenous dexmedetomidine on spinal hyperbaric ropivacaine anesthesia. J Anesth. 2010 Aug;24(4):544-8. doi: 10.1007/s00540-010-0939-9. Epub 2010 May 14.
Results Reference
background
PubMed Identifier
20039221
Citation
Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.
Results Reference
background
PubMed Identifier
23727917
Citation
Kim JE, Kim NY, Lee HS, Kil HK. Effects of intrathecal dexmedetomidine on low-dose bupivacaine spinal anesthesia in elderly patients undergoing transurethral prostatectomy. Biol Pharm Bull. 2013;36(6):959-65. doi: 10.1248/bpb.b12-01067.
Results Reference
derived

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The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly

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