Administration of Dexmedetomidine Guided by Entropy/SPI Reduce

Does Administration of Dexmedetomidine Guided by Entropy/SPI Reduce the Requirement of Propofol and Remifentanil as Well as Increase the Quality of Recovery Profile?

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Group Dex (dexmedetomidine)

Detailed Description

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.

Patients (20~65 years old, ASA class 1 or 2) scheduled lumbar discectomy under general anesthesia were recruited. The patients were randomly allocated to two groups. Both groups received Target controlled infusion(TCI) of propofol and remifentanil and the dexmedetomidine was added to the Dex group and normal saline was added to the Placebo group. 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. The placebo group received equal amount of normal saline. During maintenance of anesthesia the effect site concentration of propofol and remifentanil was titrated to maintain Entropy(SE) 40~60 and SPI under 50. Blood pressure and heart rate also was measured. The total amount of propofol and remifentanil administered, time between eye opening and extubation was recorded. The quality of recovery was evaluated by QoR-40 survey after 24 hours postop.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital, Yonsei University College of Medicine
    • Contact: Jiwon An, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Dex; 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); 1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure; Other Names: Precedex
Placebo Comparator: Group Placebo; The Placebo group received equal amount of normal saline. Interventions: ◦Drug: Normal saline	Drug: Group Dex (dexmedetomidine); 1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of quality of recovery between each groups	The quality of recovery was evaluated by QoR-40 survey after 24 hours postop.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Study Chair: Dong Woo Han, PhD, Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 3-2014-0218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No