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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01342562
First received: April 15, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Benign Prostatic Hypertrophy
Drug: spinal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Evaluation of efficacy of DXM-bupivacaine [ Time Frame: The sensory block level at every 2 minutes (up until 14 minutes) after drug injection during spinal anesthesia ] [ Designated as safety issue: No ]
    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 [ Time Frame: change in VAS(Visual Analog Scale) at 6 hours and 24 hours after surgery ] [ Designated as safety issue: No ]
    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).


Enrollment: 54
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DXM-bupivacaine Drug: spinal anesthesia
0.4% bupivacaine(normal saline 0.3ml with dexmedetomidine 3 mcg)
Placebo Comparator: saline-bupivacaine Drug: spinal anesthesia
0.4% bupivacaine(normal saline 0.3 ml with 0.5% bupivacaine 1.2 ml)

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342562

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01342562     History of Changes
Other Study ID Numbers: 4-2010-0513
Study First Received: April 15, 2011
Last Updated: March 4, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Anesthetics
Bupivacaine
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014