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

NCT02018276 | Completed DMC

• 1 other identifier: 4-2013-0719
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Lidocaine; Magnesium; Functional recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after the operation

Study Arms (2)

The effect of perioperative lidocaine infusion

EXPERIMENTAL

Drug: Lidocaine

The effect of perioperative magnesium infusion

ACTIVE COMPARATOR

Drug: Magnesium

Interventions

Lidocaine DRUG

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

The effect of perioperative lidocaine infusion

Magnesium DRUG

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)

The effect of perioperative magnesium infusion

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29324495 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Lidocaine; Magnesium

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

KR (1)