Skip to content

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?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02818621
Enrollment
64
Registered
2016-06-30
Start date
2014-10-31
Completion date
2017-10-31
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

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.

Interventions

DRUGGroup 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

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The difference of the requirements of propofol and remifentanil between each groupsthe day of surgeryWe analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine or placebo(normal saline) when using entropy and SPI.

Secondary

MeasureTime frameDescription
The difference of quality of recovery between each groups24 hours after surgeryThe quality of recovery was evaluated by QoR-40 survey after 24 hours postop.

Countries

South Korea

Contacts

Primary ContactJiwon An, MD
anzilmd@yuhs.ac2019-3520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026