Ketamine in Robot-assisted Thyroidectomy (KEThyRobot)

November 24, 2013 updated by: Hee-Pyoung Park, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 3, 6, 12, 48 and 72 hour postoperatively
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.
At 24 hours postoperatively
Analgesic requirements for 24 hours after surgery
Time Frame: at 24 hours postoperatively
Analgesic requirements for 24 hours after surgery will be evaluated.
at 24 hours postoperatively
Chronic pain at 3 month after surgery
Time Frame: At 3 month after surgery
Chronic pain at 3 month after surgery will be evaluated.
At 3 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Hee-Pyoung Park, PhD, Seoul National University of Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 24, 2013

First Posted (ESTIMATE)

November 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 24, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH_KEThyRobot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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