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

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665586
• Other study ID #: 4-2011-0927
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: July 24, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Bladder Tumor
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No