Thyroid CancerNCT02018276
Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Thyroid Surgery
A study testing Lidocaine and Magnesium in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Studies have attempted to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Lidocaine and Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Oct 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 20 and 65 who have undergone thyroidectomy due to thyroid cancer and of American Society of Anesthesiologists (ASA) Physical Status Class 1 or Class 2
Who cannot join
- Patients experiencing pain for any cause or taking an analgesic
- Pregnant patients
- Patients with severe heart, kidney, or liver disease
- Patients with a psychiatric or neurological disorder
- Patients with a contraindication or allergic response to lidocaine
- Patients with a contraindication or allergic response to magnesium
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
Studies have attempted to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli. Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control by reducing postoperative pain and opioid consumption. Another report showed that an intraoperative intravenous injection of lidocaine improved the quality of postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy patient. In addition, a review article on the effect of intraoperative intravenous injection of magnesium found it to be an effective analgesic that may be added to conventional opioid-based therapy because it generally reduces opioid consumption, decreases pain assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium administration. However, there has been insufficient research comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of which is more helpful for general functional recovery and decreased postoperative pain. Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery; to help patients return to daily life, the research trend is now shifting from the improvement or resolution of a specific symptom to the measurement of general recovery. Postoperative recovery is a complicated process related to such catamnestic factors as physiological end-points, the incidence of adverse events, and changes in psychological status. A widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey. The QoR-40 includes a total of 40 questions that may be divided into five sub-categories: emotional state, physical comfort, psychological support, physical independence, and pain. The respondent answers each question on a 5-point scale, with one being worst and five being best. The QoR-40 takes 6.3 minutes on average to complete and is known to have good test-retest reliability, internal consistency, and split-half reliability. With respect to anesthetic recovery, the QoR-40 has been used in various studies to investigate how the surgery type, anesthesia method, administration of an additional drug, and gender affect anesthesia and surgery. The validity of the QoR-40 for research purposes has already been established.
Therefore, in this study, we investigated the intraoperative intravenous injection of lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in the functional recovery of thyroidectomy patients after general anesthesia.
- Conditions
- Thyroid Cancer
- Being tested
- Lidocaine, Magnesium
- Keywords
- Lidocaine, Magnesium, Functional recovery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
The administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Lidocaine Group, 1% lidocaine 40 mL was prepared in a 50 mL syringe
MagnesiumDrug
The administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Magnesium Group, MgSO4 4g 40 mL was prepared in a 50 mL syringe)
| Study group | Role | What they receive |
|---|---|---|
| The effect of perioperative lidocaine infusion | Experimental | Not described Receives: Drug: Lidocaine |
| The effect of perioperative magnesium infusion | Active comparator | Not described Receives: Drug: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study was the QoR 40
The quality of patient recovery after general anesthesia was evaluated by summing the scores for five subcategories-emotional state, physical comfort, psychological support, physical independence, and pain-to measure the global score (maximum of 200 points). The primary endpoint of this study was the QoR 40 at 24 hours after the operation. A difference between groups was considered significant when the difference in the score between two groups was 10 points or more.
Measured: 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
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 Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018276
- Sponsor's protocol ID
- 4-2013-0719
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2013
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim MH, Kim MS, Lee JH, Kim ST, Lee JR. Intravenously Administered Lidocaine and Magnesium During Thyroid Surgery in Female Patients for Better Quality of Recovery After Anesthesia. Anesth Analg. 2018 Sep;127(3):635-641. doi: 10.1213/ANE.0000000000002797.
PubMed 29324495
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02018276
- Acronym / sponsor ID
- 4-2013-0719
- Conditions
- Thyroid Cancer
- Keywords
- Lidocaine, Magnesium, Functional recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Dec 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.
Studies have attempted to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli. Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control by reducing postoperative pain and opioid consumption. Another report showed that an intraoperative intravenous injection of lidocaine improved the quality of postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy patient. In addition, a review article on the effect of intraoperative intravenous injection of magnesium found it to be an effective analgesic that may be added to conventional opioid-based therapy because it generally reduces opioid consumption, decreases pain assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium administration. However, there has been insufficient research comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of which is more helpful for general functional recovery and decreased postoperative pain. Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery; to help patients return to daily life, the research trend is now shifting from the improvement or resolution of a specific symptom to the measurement of general recovery. Postoperative recovery is a complicated process related to such catamnestic factors as physiological end-points, the incidence of adverse events, and changes in psychological status. A widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey. The QoR-40 includes a total of 40 questions that may be divided into five sub-categories: emotional state, physical comfort, psychological support, physical independence, and pain. The respondent answers each question on a 5-point scale, with one being worst and five being best. The QoR-40 takes 6.3 minutes on average to complete and is known to have good test-retest reliability, internal consistency, and split-half reliability. With respect to anesthetic recovery, the QoR-40 has been used in various studies to investigate how the surgery type, anesthesia method, administration of an additional drug, and gender affect anesthesia and surgery. The validity of the QoR-40 for research purposes has already been established.
Therefore, in this study, we investigated the intraoperative intravenous injection of lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in the functional recovery of thyroidectomy patients after general anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effect of perioperative lidocaine infusion | Experimental | Drug: Lidocaine |
| The effect of perioperative magnesium infusion | Active comparator | Drug: Magnesium |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 20 and 65 who have undergone thyroidectomy due to thyroid cancer and of American Society of Anesthesiologists (ASA) Physical Status Class 1 or Class 2
Key exclusion criteria (6 listed)
- Patients experiencing pain for any cause or taking an analgesic
- Pregnant patients
- Patients with severe heart, kidney, or liver disease
- Patients with a psychiatric or neurological disorder
- Patients with a contraindication or allergic response to lidocaine
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 |
|---|---|---|
| LidocaineThe administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Lidocaine Group, 1% lidocaine 40 mL was prepared in a 50 mL syringe | Drug | The effect of perioperative lidocaine infusion |
| MagnesiumThe administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Magnesium Group, MgSO4 4g 40 mL was prepared in a 50 mL syringe) | Drug | The effect of perioperative magnesium infusion |
Primary outcome
The primary endpoint of this study was the QoR 40
Time frame: 24 hours after the operation
The quality of patient recovery after general anesthesia was evaluated by summing the scores for five subcategories-emotional state, physical comfort, psychological support, physical independence, and pain-to measure the global score (maximum of 200 points). The primary endpoint of this study was the QoR 40 at 24 hours after the operation. A difference between groups was considered significant when the difference in the score between two groups was 10 points or more.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Derived from this study: PubMed 29324495Kim MH, Kim MS, Lee JH, Kim ST, Lee JR. Intravenously Administered Lidocaine and Magnesium During Thyroid Surgery in Female Patients for Better Quality of Recovery After Anesthesia. Anesth Analg. 2018 Sep;127(3):635-641. doi: 10.1213/ANE.0000000000002797.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Magnesium in people with Thyroid Cancer, run by Yonsei University 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 2 Feb 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study was the QoR 40 (time frame: 24 hours after the operation). 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 NCT02018276, 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 2 Feb 2015.