Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Thyroid Surgery

January 30, 2015 updated by: Yonsei University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effect of perioperative lidocaine infusion
Drug: Lidocaine
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
Active Comparator: The effect of perioperative magnesium infusion
Drug: Magnesium
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0719

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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