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Ketamine in Robot-assisted Thyroidectomy (KEThyRobot)

Primary Purpose

Thyroid, Acute Pain, Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketamine infusion
NS infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid focused on measuring Thyroidectomy, Endoscopy, Ketamine, Acute Pain, Chronic Pain, Postoperative period

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

C group

KET group

Arm Description

In C group, NS infusion will be done intraoperatively.

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).

Outcomes

Primary Outcome Measures

Pain 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

Pain 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)
Time to the first analgesics postoperatively
Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.
Analgesic requirements for 24 hours after surgery
Analgesic requirements for 24 hours after surgery will be evaluated.
Chronic pain at 3 month after surgery
Chronic pain at 3 month after surgery will be evaluated.

Full Information

First Posted
November 18, 2013
Last Updated
November 24, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01997801
Brief Title
Ketamine in Robot-assisted Thyroidectomy
Acronym
KEThyRobot
Official Title
The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Acute Pain, Chronic Pain
Keywords
Thyroidectomy, Endoscopy, Ketamine, Acute Pain, Chronic Pain, Postoperative period

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C group
Arm Type
Placebo Comparator
Arm Description
In C group, NS infusion will be done intraoperatively.
Arm Title
KET group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine infusion
Intervention Description
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
Intervention Type
Drug
Intervention Name(s)
NS infusion
Intervention Description
Normal saline will be infused intraoperatively.
Primary Outcome Measure Information:
Title
Pain at 24 hour postoperatively
Description
Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)
Time Frame
at 24 hour postoperatively
Secondary Outcome Measure Information:
Title
Pain at 3, 6, 12, 48 and 72 hour postoperatively
Description
Pain at 3, 6, 12, 48 and 72 hour postoperatively will be evaluated using 11-point scale 0:no pain, 10:worst imaginable)
Time Frame
at 3, 6, 12, 48 and 72 hour postoperatively
Title
Time to the first analgesics postoperatively
Description
Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.
Time Frame
At 24 hours postoperatively
Title
Analgesic requirements for 24 hours after surgery
Description
Analgesic requirements for 24 hours after surgery will be evaluated.
Time Frame
at 24 hours postoperatively
Title
Chronic pain at 3 month after surgery
Description
Chronic pain at 3 month after surgery will be evaluated.
Time Frame
At 3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Pyoung Park, PhD
Phone
+82-10-2971-7647
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Chang Kim, MD
Phone
+82-10-2886-2876
Email
onidori1979@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD
Phone
+82-10-2971-7647
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyun-Chang Kim, MD
Phone
+82-10-2886-2876
Email
onidori1979@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29124992
Citation
Lee J, Park HP, Jeong MH, Son JD, Kim HC. Efficacy of ketamine for postoperative pain following robotic thyroidectomy: A prospective randomised study. J Int Med Res. 2018 Mar;46(3):1109-1120. doi: 10.1177/0300060517734679. Epub 2017 Nov 10.
Results Reference
derived

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Ketamine in Robot-assisted Thyroidectomy

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