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Administration of Dexmedetomidine Guided by Entropy/SPI Reduce

NCT ID: NCT02818621

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Group Dex (dexmedetomidine)

Intervention Type DRUG

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

Group Placebo

The Placebo group received equal amount of normal saline.

Interventions:

◦Drug: Normal saline

Group Type PLACEBO_COMPARATOR

Group Dex (dexmedetomidine)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiwon An

Associate Porfessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Woo Han, PhD

Role: STUDY_CHAIR

Gangnam Severance Hospital

Locations

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Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jiwon An, MD

Role: CONTACT

Phone: 2019-3520

Email: [email protected]

Facility Contacts

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Jiwon An, MD

Role: primary

Other Identifiers

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3-2014-0218

Identifier Type: -

Identifier Source: org_study_id