Ketamine in Robot-assisted Thyroidectomy

NCT ID: NCT01997801

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Thyroid Acute Pain Chronic Pain

Keywords

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Thyroidectomy Endoscopy Ketamine Acute Pain Chronic Pain Postoperative period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C group

In C group, NS infusion will be done intraoperatively.

Group Type PLACEBO_COMPARATOR

NS infusion

Intervention Type DRUG

Normal saline will be infused intraoperatively.

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).

Group Type EXPERIMENTAL

Ketamine infusion

Intervention Type DRUG

Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).

Interventions

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Ketamine infusion

Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).

Intervention Type DRUG

NS infusion

Normal saline will be infused intraoperatively.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Pyoung Park, PhD

Role: STUDY_DIRECTOR

Seoul National University of Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hee-Pyoung Park, PhD

Role: CONTACT

Phone: +82-10-2971-7647

Email: [email protected]

Hyun-Chang Kim, MD

Role: CONTACT

Phone: +82-10-2886-2876

Email: [email protected]

Facility Contacts

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Hee-Pyoung Park, PhD

Role: primary

Hyun-Chang Kim, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 29124992 (View on PubMed)

Other Identifiers

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SNUH_KEThyRobot

Identifier Type: -

Identifier Source: org_study_id