ThyroidKEThyRobotNCT01997801
Ketamine in Robot-assisted Thyroidectomy
A study testing Ketamine infusion and NS infusion in people with Thyroid and Acute Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Thyroid, Acute Pain, Chronic Pain
- What is being tested?
- Ketamine infusion and NS infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for robot-assisted thyroidectomy
- ASA I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, 110-744
Hee-Pyoung Park, PhD, +82-10-2971-7647, hppark@snu.ac.kr
Hyun-Chang Kim, MD, +82-10-2886-2876, onidori1979@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid, Acute Pain, Chronic Pain
- Being tested
- Ketamine infusion, NS infusion
- Keywords
- Thyroidectomy, Endoscopy, Ketamine, Acute Pain, Chronic Pain, Postoperative period
- Medical subject headings
- Thyroid Diseases, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine infusionDrug
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
NS infusionDrug
Normal saline will be infused intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| C group | Placebo comparator | In C group, NS infusion will be done intraoperatively. Receives: Drug: NS infusion |
| KET group | Experimental | 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). Receives: Drug: Ketamine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at 24 hour postoperatively
Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)
Measured: at 24 hour postoperatively
Secondary outcomes (4)
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)
Measured: at 3, 6, 12, 48 and 72 hour postoperatively
Time to the first analgesics postoperatively
Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.
Measured: At 24 hours postoperatively
Analgesic requirements for 24 hours after surgery
Analgesic requirements for 24 hours after surgery will be evaluated.
Measured: at 24 hours postoperatively
Chronic pain at 3 month after surgery
Chronic pain at 3 month after surgery will be evaluated.
Measured: At 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee-Pyoung Park, PhD, Study director, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997801
- Sponsor's protocol ID
- SNUH_KEThyRobot
- Acronym
- KEThyRobot
- Status last verified
- Nov 2013
- First submitted
- 18 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29124992
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
- ClinicalTrials.gov ID
- NCT01997801
- Acronym / sponsor ID
- KEThyRobot / SNUH_KEThyRobot
- Conditions
- Thyroid, Acute Pain, Chronic Pain
- Keywords
- Thyroidectomy, Endoscopy, Ketamine, Acute Pain, Chronic Pain, Postoperative period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C group | Placebo comparator | Drug: NS infusionIn C group, NS infusion will be done intraoperatively. |
| KET group | Experimental | Drug: Ketamine infusionIn KET group, ketamine infusion will be done intraoperatively(0.25 mg/kg bolus injection following 100 mcg/kg/hr till the end of surgery). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for robot-assisted thyroidectomy
- ASA I-III
Key exclusion criteria (8 listed)
- Patients with renal dysfunction
- Patients with hepatic dysfunction
- Patients with neurologic dysfunction
- Patients with the history of drug addiction
- Patients with chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine infusionKetamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr). | Drug | KET group |
| NS infusionNormal saline will be infused intraoperatively. | Drug | C group |
Primary outcome
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)
4 secondary outcomes
Pain at 3, 6, 12, 48 and 72 hour postoperatively
Time frame: at 3, 6, 12, 48 and 72 hour postoperatively
Time to the first analgesics postoperatively
Time frame: At 24 hours postoperatively
Analgesic requirements for 24 hours after surgery
Time frame: at 24 hours postoperatively
Chronic pain at 3 month after surgery
Time frame: At 3 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Derived from this study: PubMed 29124992Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Pyoung Park, PhD study director
Seoul National University of Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine infusion and NS infusion in people with Thyroid and Acute Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Pyoung Park, PhD (+82-10-2971-7647, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at 24 hour postoperatively (time frame: at 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.