Tremor Clinical Trial
Official title:
Does Higher Operation Theatre Ambient Temperature and Intravenous Ondansetron Prophylaxis Reduce Incidence of Post-spinal Shivering in Obstetric Population? A Double-blind, Randomised, Factorial Study.
This study will look at the incidence of post-spinal shivering (PSS) among the obstetrics population and will investigate whether higher operation theater (OT) temperature range or/and IV Ondansetron are able to reduce the incidence of PSS. This is a double-blind, randomized, factorial study, patients will be grouped into 4 groups - LP, HP, LO, HO (L= low-temperature range, H= high-temperature range, P= placebo, O=Ondansetron). All patients undergoing cesarean section under spinal anesthesia will be recruited, and it will be conducted in obstetrics OT.
Many studies have been conducted to look at methods to prevent and treat postspinal shivering. However, there is still no clear protocol or gold standard for post-spinal shivering management. This is due to the fact that post-spinal shivering mechanisms are complex and are broadly grouped into thermoregulatory and non-thermoregulatory. Preventive measures that have been studied are broadly classified into pharmacological methods and non-pharmacological methods. For Non-pharmacological method, active warming of the patient by various methods have been found to be effective in preventing PSS. However, there is no study that looks at ways to reduce heat loss hence maintaining normothermia and preventing PSS in patients. Therefore in this study, we will be investigating if higher OT temperature will reduce the incidence of PSS. As for pharmacological methods, many drugs have been studied for examples analgesics (tramadol), opioid receptor agonists (pethidine, fentanyl), cholinesterase inhibitors (physostigmine), N-methyl-D-aspartate receptor antagonists (ketamine, magnesium sulphate), α2-central agonists (clonidine, dexmedetomidine), antiserotonergic (ondansetron) and anti-inflammatory drugs (dexamethasone). Ondansetron is usually used to prevent chemotherapy or radiotherapy-induced nausea vomiting and Post-operative nausea and vomiting. Due to the fact that it is generally a safe drug and has added benefit as an anti-emetics especially for obstetrics population, this drug is chosen to be studied. We will also look at the efficacy of the combined effect of increased OT temperature and prophylaxis ondansetron on preventing PSS. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02427646 -
Kinematic-guided BoNT-A Treatment for ET and PD Tremor
|
Phase 2 | |
Completed |
NCT01018485 -
The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
|
Phase 3 | |
Completed |
NCT02087046 -
Deep Brain Stimulation (DBS) for the Suppression of Tremor
|
N/A | |
Recruiting |
NCT05413291 -
Natural History Protocol for Movement Disorders
|
||
Recruiting |
NCT04825119 -
Hyperkinetic Movements in Patients With Disease of Motor Neurons and Their Response to Treatment With Nusinersen
|
||
Recruiting |
NCT05150106 -
Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
|
||
Completed |
NCT05152836 -
The Effect of Vibrotactile Stimulation on Parkinson's Tremor
|
N/A | |
Recruiting |
NCT04071847 -
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
|
||
Completed |
NCT02046863 -
Pilot Study for Automated Deep Brain Stimulation Programming
|
N/A | |
Not yet recruiting |
NCT06378619 -
Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach
|
||
Completed |
NCT03300193 -
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
|
N/A | |
Completed |
NCT01932463 -
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor
|
N/A | |
Recruiting |
NCT05216770 -
Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor
|
Early Phase 1 | |
Not yet recruiting |
NCT06174948 -
The Use of the CUE1 in People With Parkinson's Disease and Related Disorders
|
N/A | |
Completed |
NCT01093027 -
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
|
N/A | |
Completed |
NCT00001667 -
Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases
|
N/A | |
Completed |
NCT00001324 -
PET Scan to Study Brain Control of Human Movement
|
||
Completed |
NCT04299087 -
Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
|
N/A | |
Recruiting |
NCT05150093 -
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
|
N/A | |
Not yet recruiting |
NCT05456451 -
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
|
N/A |