Ketamine in Robot-assisted Thyroidectomy

Ketamine

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.

Intervention / Treatment

  • Ketamine Infusion (DRUG)
    Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
  • NS infusion (DRUG)
    Normal saline will be infused intraoperatively.

Condition or Disease

  • Thyroid
  • Acute Pain
  • Chronic Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 19 Years to 80 Years
    Enrollment: 64 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2013
    Primary Completion: Dec 01, 2014 ESTIMATED
    Completion Date: Dec 01, 2014 ESTIMATED
    Study First Posted: Nov 28, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 24, 2013

    Sponsors / Collaborators

    Lead Sponsor: Seoul National University Hospital
    Responsible Party: N/A

    Location

    South Korea
    Seoul, South Korea

    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.

    Participant Groups

    • 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).

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)

    Secondary Outcomes

    • Pain at 3, 6, 12, 48 and 72 hour postoperatively will be evaluated using 11-point scale 0:no pain, 10:worst imaginable)

    • 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 will be evaluated.

    • Chronic pain at 3 month after surgery will be evaluated.

    More Details

    NCT Number: NCT01997801
    Acronym: KEThyRobot
    Other IDs: SNUH_KEThyRobot
    Study URL: https://clinicaltrials.gov/study/NCT01997801
    Last updated: Sep 29, 2023