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Clinical Trials/NCT01997801
NCT01997801
Unknown
Not Applicable

The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy

Seoul National University Hospital1 site in 1 country64 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
NS infusion
Conditions
Thyroid
Sponsor
Seoul National University Hospital
Enrollment
64
Locations
1
Primary Endpoint
Pain at 24 hour postoperatively
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Pyoung Park

Associate professor

Seoul National University Hospital

Eligibility 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

Arms & Interventions

C group

In C group, NS infusion will be done intraoperatively.

Intervention: NS infusion

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).

Intervention: Ketamine infusion

Outcomes

Primary Outcomes

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 Outcomes

  • Chronic pain at 3 month after surgery(At 3 month after surgery)
  • Analgesic requirements for 24 hours after surgery(at 24 hours postoperatively)
  • Pain at 3, 6, 12, 48 and 72 hour postoperatively(at 3, 6, 12, 48 and 72 hour postoperatively)
  • Time to the first analgesics postoperatively(At 24 hours postoperatively)

Study Sites (1)

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