Administration of Dexmedetomidine Guided by Entropy/SPI Reduce

NCT02818621 | Unknown

• 1 other identifier: 3-2014-0218
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and opioid requirements due to its sedative and analgesic properties. However, until now, there has been studies based on indirect measures such as hemodynamics. Entropy shows to quantify the level of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect of pain stimuli and analgesic therapy by the index of the nociception-anti-nociception balance. The investigators analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine when using entropy and SPI.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The difference of the requirements of propofol and remifentanil between each groups

  We analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine or placebo(normal saline) when using entropy and SPI.

  the day of surgery

Secondary Outcomes (1)

• The difference of quality of recovery between each groups

  24 hours after surgery

Study Arms (2)

Group Dex

ACTIVE COMPARATOR

The Dex group received 1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure. Interventions: ◦Drug: Dexmedetomidine

Drug: Group Dex (dexmedetomidine)

Group Placebo

PLACEBO COMPARATOR

The Placebo group received equal amount of normal saline. Interventions: ◦Drug: Normal saline

Drug: Group Dex (dexmedetomidine)

Interventions

Group Dex (dexmedetomidine) DRUG

1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure

Also known as: Precedex

Group Dex; Group Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients (20\~65 years old, ASA class 1 or 2) scheduled lumbar discectomy under general anesthesia

You may not qualify if:

• ASA class (American Society of Anesthesiologist physical status classification) 3 or higher
• Patients with history of allergy or side effects on propofol, remifentanil, dexmedetomidine
• BMI (body mass index) higher than 35
• Patients taking monoamine oxidase inhibitor or adrenergic blocking agent
• Pregnancy, Emergency operation
• Patients with liver disease, cognitive dysfunction or drug abuse history

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dong Woo Han, PhD

  Gangnam Severance Hospital

  STUDY CHAIR

Central Study Contacts

Jiwon An, MD

CONTACT

2019-3520; anzilmd@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Porfessor

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 30, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)