Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649318
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Effect of Brain GABA Metabolite Amount to Propofol Utilisation Under TIVA in Hypothyroid Patient
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Brain GABA Metabolite Amount to Propofol Utilisation Under TIVA in Hypothyroid Patient
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrainGABA
Brief Summary:
Introduction GABAergic synaptic transmigration in the anterior cingulate ACC cortex of hypothyroid rats has been demonstrated by electrophysiologic recordings Propofol is an agent acting through GABA receptors In our study our 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 Our 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 our study included patients with ASA I-II status Group 1 Control group n40 patients with regular thyroid function tests and Group 2 Hypothyroid group n40 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 and they 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 22-24 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 we set our sequence with optimal parameters for which we set the radio frequency pulse-echo time TE as 20 msec We set the voxel size as 233 cm to obtain optimal results We determined our 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 Induction was performed with 2 mgkg propofol 05 mgkg fentanyl and 05 mgkg rocuronium Maintenance was achieved by bispectral index monitoring with propofol infusion at a dose of 1-8 mgkgmin and remifentanil infusion at a dose of 05-2 mcgkgmin with values between 40-60
Method After ethics committee approval our study included patients with ASA I-II status Group 1 Control group n40 patients with regular thyroid function tests and Group 2 Hypothyroid group n40 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 and they 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 22-24 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 we set our sequence with optimal parameters for which we set the radio frequency pulse-echo time TE as 20 msec We set the voxel size as 233 cm to obtain optimal results We determined our 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 Induction was performed with 2 mgkg propofol 05 mgkg fentanyl and 05 mgkg rocuronium Maintenance was achieved by bispectral index monitoring with propofol infusion at a dose of 1-8 mgkgmin and remifentanil infusion at a dose of 05-2 mcgkgmin with values between 40-60
Detailed Description:
It is generally accepted that thyroid hormones have important effects on the normal functioning of the adult brain Hypothyroidism is a common endocrine disorder characterized by low secretion of thyroid hormone It is often associated with cognitive and neuropsychiatric changes Multimodal imaging studies have demonstrated structural and functional changes in the brain in patients with hypothyroidism Publications have reported decreased hippocampal area microstructural changes in brain white matter changes in brain metabolic rate decreased regional blood flow decreased cerebral glucose metabolism decreased functional connectivity and decreased cortical excitability
It is noteworthy that the hormone affects GABAergic neurotransmission Preclinical studies have shown that T3 and T4 hormones modulate GABA receptor activity Recent studies in rat hippocampus have shown a decrease in GABA levels in the hippocampus in the hypothyroid group Anesthetic drugs that we use as daily routine anesthetic applications in the clinic for general anesthesia mostly show their effects through GABA receptors Therefore we argue that in thyroid hormone disorders which are effective on the GABAergic system the need for anesthetic substances routinely used during general anesthesia may vary compared to patients with normal thyroid function
In our study we aimed to observe whether there is a difference between the anesthetic substance requirements of patients with normal thyroid function and hypothyroid patients under general anesthesia with monitoring We also aimed to observe whether there is a regional difference in non-contrast MR spectroscopic evaluation in patients with normal and low thyroid dysfunction There were no invasive procedures in our study
It is noteworthy that the hormone affects GABAergic neurotransmission Preclinical studies have shown that T3 and T4 hormones modulate GABA receptor activity Recent studies in rat hippocampus have shown a decrease in GABA levels in the hippocampus in the hypothyroid group Anesthetic drugs that we use as daily routine anesthetic applications in the clinic for general anesthesia mostly show their effects through GABA receptors Therefore we argue that in thyroid hormone disorders which are effective on the GABAergic system the need for anesthetic substances routinely used during general anesthesia may vary compared to patients with normal thyroid function
In our study we aimed to observe whether there is a difference between the anesthetic substance requirements of patients with normal thyroid function and hypothyroid patients under general anesthesia with monitoring We also aimed to observe whether there is a regional difference in non-contrast MR spectroscopic evaluation in patients with normal and low thyroid dysfunction There were no invasive procedures in our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None