Administration of Dexmedetomidine Guided by Entropy/SPI Reduce

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02818621
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Group Dex (dexmedetomidine)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Does Administration of Dexmedetomidine Guided by Entropy/SPI Reduce the Requirement of Propofol and Remifentanil as Well as Increase the Quality of Recovery Profile?
• Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The difference of the requirements of propofol and remifentanil between each groups [the day of surgery]

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

Secondary Outcome Measures

1. The difference of quality of recovery between each groups [24 hours after surgery]

   The quality of recovery was evaluated by QoR-40 survey after 24 hours postop.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiwon An, Associate Porfessor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT02818621
• Other Study ID Numbers: 3-2014-0218
• First Posted: Jun 30, 2016
• Last Update Posted: Jun 30, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Jun 30, 2016