Effective Dose of Dexmedetomidine for Sedation in Elderly Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Recently many studies reported that intra-operative 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 olds) 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 fentanil 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.
| Condition | Intervention |
|---|---|
|
Benign Prostate Hyperplasia Bladder Tumor |
Drug: dexmedetomidine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
- Observer's Assessment of Alertness/Sedation scale, OAA/S [ Time Frame: from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery. ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group C
: Spinal anesthesia with 6mg bupivacaine and intrathecal placebo(normal saline) added
|
Drug: dexmedetomidine
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 |
|
Active Comparator: Group F
: Spinal anesthesia with 6mg bupivacaine and intrathecal small dose of fentanyl(20micro gram)
|
Drug: dexmedetomidine
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 |
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Hae-Keum Kil, MD | 82-2-2228-2420 | HKKIL@yuhs.ac |
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Hae-Keum Kil, MD 82-2-2228-2420 HKKIL@yuhs.ac | |
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01665586 History of Changes |
| Other Study ID Numbers: | 4-2011-0927 |
| Study First Received: | July 31, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
dexmedetomidine sedation in elderly patient spinal anesthesia |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Urinary Bladder Neoplasms Hyperplasia Prostatic Diseases Genital Diseases, Male Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Pathologic Processes Anesthetics Fentanyl Dexmedetomidine |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Hypnotics and Sedatives Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on May 23, 2013