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

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.

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Key information

Conditions

Benign Prostate Hyperplasia Bladder Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Hyperplasia Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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.

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 15, 2012
Registry last updated: Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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