Effect of Brain GABA Metabolite Amount to Propofol Utilisation Under TIVA in Hypothyroid Patient

NCT06649318 | Completed

• 1 other identifier: 2023-117
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: GABAergic synaptic transmigration in the anterior cingulate (ACC) cortex of hypothyroid rats has been demonstrated by electrophysiologic recordings. In this study, the investigators primary aim was to determine whether the dose requirement of propofol used under the guidance of bispectral index monitoring is correlated with thyroid hormone levels in patients undergoing surgery under total intravenous anaesthesia.The investigators secondary aim was to determine whether there is a difference in the amount of GABA metabolite in the midline posterior (mPCC) and midline anterior cingulate cortex (mACC) region in normal and thyroid dysfunction patients on magnetic resonance spectroscopic imaging. Method: After ethics committee approval, the study included patients with ASA I-II status: Group 1 (Control group n=40) patients with regular thyroid function tests and Group 2 (Hypothyroid group n=40) patients with hypothyroidism history with Levothyroxine sodium treated. Patients were evaluated preoperatively with the Montreal assessment scale and Beck anxiety scale. Written informed consent was obtained from all the patients, andparticipants underwent a brain MRI examination one day before the operation. The possible increase of GABA, which is present in the imaging with NAA, Cr and Glx in the range of 2.2-2.4 ppm, was recorded as an elevated spectral curve in the MR spectroscopy spectrum and its numerical equivalent was determined as the amount of chemical shifting in the y-axis. To determine GABA, the investigators set the sequence with optimal parameters, for which the investigators set the radio frequency pulse-echo time (TE) as 20 msec.The investigators set the voxel size as 2\*3\*3 cm to obtain optimal results. Researchers determined single voxel imaging MR spectroscopy sampling area in the midline anterior and posterior to the cingulate gyrus in all patients. Patients with spectral voxels outside the specified area, dense ventricular contamination within the voxel, or with intra-voxel dense ventricular contamination or seminal contamination were excluded from the study. Patients were operated on under total intravenous anaesthesia. Anesthesia Induction was performed with 2 mg/kg propofol, 0.5 mg/kg fentanyl and 0.5 mg/kg rocuronium. Maintenance was achieved by bispectral index monitoring with propofol infusion at a dose of 1-8 mg/kg/min and remifentanil infusion at a dose of 0.5-2 mcg/kg/min with values between 40-60.

Conditions

Hypothyroidism; Anesthesia, General; Propofol Dosage; Magnetic Resonance Imaging (MRI); Remifentanil; Gamma Aminobutyric Acid

Keywords

Hypothyroid patient; GABA metabolites; Magnetic resonance spectroscopy screening; propofol; remifentanyl; anesthesia

Outcome Measures

Primary Outcomes (1)

• Changes of participants' thyroid hormone levels measured before anesthesia and doses of propofol and remifentanil used in total intravenous anesthesia under bispectral index monitoring.

  The difference of participants' thyroid hormone levels (IU/mL) before anesthesia and compare the doses of propofol in miligram and remifentanil in microgram used in total intravenous anesthesia under bispectral index monitoring.

  From enrollment to the end of treatment at 1 day

Secondary Outcomes (1)

• Changes in the amounts of brain GABA metabolites chemical shifts measured in ppm units between participants with hypothyroidism and participants with normal thyroid function before anesthesia. .

  From enrollment to the end of treatment at 1 day

Study Arms (2)

Group 1

Control group (n=40) Patients with normal thyroid function tests

Group 2

Hypothyroid patients group (n=40) . Hypothyroid and treated with Levothyroxine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ASAI-II status, older than 18 years and younger than 65 years who will be operated under total intravenous anesthesia

You may qualify if:

• Patients older than 18 years and younger than 65 years who will be operated under total intravenous anesthesia
• ASAI-II status

You may not qualify if:

• Patients for whom Intensive Care Unit (ICU) indication is foreseen
• Chronic obstructive pulmonary disease,
• A personal or family history of malignant hyperthermia,
• Alcohol or drug addiction,
• History of liver or kidney disease,
• With coronary artery disease or heart failure,
• Significant anemia or hemoglobinopathy,
• Hypotension, hypovolemia, sepsis,
• Unregulated diabetic patients,
• Female patients who are pregnant or lactating.
• Allergic to propofol and halogens
• Patients on gabapentinoids
• Those with a history of head trauma
• Those with neurological disorders

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, DU, 81620, Turkey (Türkiye)

Location

Related Publications (3)

• Brohan J, Goudra BG. The Role of GABA Receptor Agonists in Anesthesia and Sedation. CNS Drugs. 2017 Oct;31(10):845-856. doi: 10.1007/s40263-017-0463-7.

  PMID: 29039138 BACKGROUND

• Fu X, Sun P, Zhang X, Zhu D, Qin Q, Lu J, Wang J. GABA in the anterior cingulate cortex mediates the association of white matter hyperintensities with executive function: a magnetic resonance spectroscopy study. Aging (Albany NY). 2024 Mar 1;16(5):4282-4298. doi: 10.18632/aging.205585. Epub 2024 Mar 1.

  PMID: 38441529 BACKGROUND

• Yi J, Zheng JY, Zhang W, Wang S, Yang ZF, Dou KF. Decreased pain threshold and enhanced synaptic transmission in the anterior cingulate cortex of experimental hypothyroidism mice. Mol Pain. 2014 Jun 18;10:38. doi: 10.1186/1744-8069-10-38.

  PMID: 24943008 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: June 23, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

TU (1)