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Ketamine in Robot-assisted Thyroidectomy (KEThyRobot)

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ClinicalTrials.gov Identifier: NCT01997801
Recruitment Status : Unknown
Verified November 2013 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Brief Summary:
In this prospective double-blinded study, The investigators compared acute postoperative pain and rescue analgesic demand during postoperative period after robot thyroidectomy between ketamine and placebo groups.

Condition or disease Intervention/treatment Phase
Thyroid Acute Pain Chronic Pain Drug: Ketamine infusion Drug: NS infusion Not Applicable

Detailed Description:
Robot-assisted endoscopic thyroidectomy has been popularized due to cosmetic advantages. Despite small incisions, robot thyroidectomy did not offer satisfactory reduction in postoperative pain compared to open thyroidectomy. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor blocker and takes some attractive advantages in terms of pain control. When low dose ketamine is perioperatively administrated, opioid sparing effect during postoperative period is reported in various surgical procedures such as spine, thoracic, and gynecologic surgery. Ketamine's beneficial effect on postoperative pain has not been investigated in patients undergoing robot thyroidectomy. The investigators hypothesized that perioperative ketamine administration can reduce acute postoperative pain after robot thyroidectomy and the incidence of chronic pain hypoesthesia on anterior chest at 3 months after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: C group
In C group, NS infusion will be done intraoperatively.
Drug: NS infusion
Normal saline will be infused intraoperatively.

Experimental: KET group
In KET group, ketamine infusion will be done intraoperatively(0.25 mg/kg bolus injection following 100 mcg/kg/hr till the end of surgery).
Drug: Ketamine infusion
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).




Primary Outcome Measures :
  1. Pain at 24 hour postoperatively [ Time Frame: at 24 hour postoperatively ]
    Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)


Secondary Outcome Measures :
  1. Pain at 3, 6, 12, 48 and 72 hour postoperatively [ Time Frame: at 3, 6, 12, 48 and 72 hour postoperatively ]
    Pain at 3, 6, 12, 48 and 72 hour postoperatively will be evaluated using 11-point scale 0:no pain, 10:worst imaginable)

  2. Time to the first analgesics postoperatively [ Time Frame: At 24 hours postoperatively ]
    Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.

  3. Analgesic requirements for 24 hours after surgery [ Time Frame: at 24 hours postoperatively ]
    Analgesic requirements for 24 hours after surgery will be evaluated.

  4. Chronic pain at 3 month after surgery [ Time Frame: At 3 month after surgery ]
    Chronic pain at 3 month after surgery will be evaluated.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for robot-assisted thyroidectomy
  • ASA I-III

Exclusion Criteria:

  • Patients with renal dysfunction
  • Patients with hepatic dysfunction
  • Patients with neurologic dysfunction
  • Patients with the history of drug addiction
  • Patients with chronic pain
  • Patients who are allergic to ketamine
  • Patients with increased ocular or intracranial pressure
  • Patients with the risk of aspiration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997801


Contacts
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Contact: Hee-Pyoung Park, PhD +82-10-2971-7647 hppark@snu.ac.kr
Contact: Hyun-Chang Kim, MD +82-10-2886-2876 onidori1979@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hee-Pyoung Park, PhD    +82-10-2971-7647    hppark@snu.ac.kr   
Contact: Hyun-Chang Kim, MD    +82-10-2886-2876    onidori1979@gmail.com   
Principal Investigator: Hee-Pyoung Park, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Hee-Pyoung Park, PhD Seoul National University of Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hee-Pyoung Park, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01997801     History of Changes
Other Study ID Numbers: SNUH_KEThyRobot
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by Hee-Pyoung Park, Seoul National University Hospital:
Thyroidectomy
Endoscopy
Ketamine
Acute Pain
Chronic Pain
Postoperative period

Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action