NCT02818621

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-06-30
• Last updated: 2016-06-30

Locations

1 site across 1 country: South Korea