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

NCT01665586 | Completed

• 1 other identifier: 4-2011-0927
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostate Hyperplasia; Bladder Tumor

Keywords

dexmedetomidine; sedation in elderly patient; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery.

Study Arms (2)

Group C

PLACEBO COMPARATOR

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

Drug: dexmedetomidine

Group F

ACTIVE COMPARATOR

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

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

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

Group C; Group F

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25971886 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 15, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

KR (1)