- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616364
Compair Efficacy of iv Dexmedetomidine & Tramadol for Post Spinal Shivering in Obs Patients Undergoing Cesarean Section
Comparison of the Efficacy of Intravenous Dexmedetomidine and Tramadol in Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment Cesarean Section
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When opposed to general anaesthesia (GA), spinal anaesthesia (SA) is recommended during caesarean section (CS) because of various advantages, including the prevention of GA-related neurotoxicity, its early onset and ease of administration, and the reduction of post-operative pain. Intraoperative shivering is the most prevalent irritating and inconvenient complication of spinal anaesthesia, and it is a very distressing experience that causes physiological stress to both patients and perioperative physicians and operating surgeons. Shivering is a skeletal muscular movement that occurs involuntarily and repeatedly. It's a common post-anesthesia adverse effect, with a 40-70% incidence rate.Shivering is not only physically unpleasant for the sufferer, but it can also have several negative consequences. It can cause pain, and discomfort for patients, obstruct monitoring techniques, raise intraocular and intracranial pressures, and double or even triple oxygen and carbon dioxide intake.Various pharmacological and non-pharmacological strategies for managing intraoperative shivering are discussed.
Tramadol, a centrally acting analgesic with -opioid agonist properties and little action on kappa and delta receptors, has been proven to be beneficial in preventing post-spinal shivering. The method of action is thought to be through a modulatory influence on central monoaminergic pathways, which inhibits noradrenaline and serotonin neuronal absorption in the spinal cord while boosting hydroxyltryptamine production, resetting the body temperature regulatory center.However, it has many side effects, including nausea, vomiting, and dizziness, which add to the patient's pain. Hence research into novel solutions with adequate safety and effectiveness is strongly advised. In this sense, despite taking into account the gold standard for post spinal shivering control is pethidine. it is contraindicated in breastfeeding which is both legally and ethically challenging for women.
Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic, and opioid-sparing alpha 2 adrenergic agonist with good selectivity and specificity.It has been shown to lower the threshold for shivering.Dexmedetomidine does not affect the locus ceruleus of the spinal cord, and it does not cause respiratory depression. In postoperative patients, dexmedetomidine lowers cortisol and norepinephrine levels, as well as blood glucose, interleukin (IL)-6, tumour necrosis factor-a, and C-reactive protein, and raises interleukin-10. Moreover, because Dexmedetomidine does not affect upper airway reflexes, it is an excellent option.It was believed that the sedative impact of intravenous injection on newborn infants was very minimal and could be disregarded due to the delayed sedative effects.
These drugs have well-defined roles to blunt the "shivering response" and hence have been used in different comparative studies to develop the single best drug of choice. Yet, there is no consensus over a single drug. In our research, we intend to compare IV Tramadol and IV Dexmedetomidine for controlling post spinal shivering in obstetric patients. The study aims to search for the best drug for blunting the shivering response, which may prove fatal in any patient.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient who will give consent
- ASA 2 patients
- Female gender of age 18 to 38
Exclusion Criteria:
- Patient allergic to any drugs
- Uncontrolled HTN
- Antepartum
- Cardiomyopathy
- Peripartum haemorrhage
- Eclampsia
- Patients refuse to give consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dexmedetomidine
Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic, and opioid-sparing alpha 2 adrenergic agonist with good selectivity and specificity.It has been shown to lower the threshold for shivering.
Dexmedetomidine does not affect the locus ceruleus of the spinal cord, and it does not cause respiratory depression.
[8] In postoperative patients, dexmedetomidine lowers cortisol and norepinephrine levels, as well as blood glucose, interleukin (IL)-6, tumour necrosis factor-a, and C-reactive protein, and raises interleukin-10.
Moreover, because Dexmedetomidine does not affect upper airway reflexes, it is an excellent option.It was believed that the sedative impact of intravenous injection on newborn infants was very minimal and could be disregarded due to the delayed sedative effects
|
Dexmedetomidine intravenous
|
EXPERIMENTAL: Tramadol
Tramadol, a centrally acting analgesic with -opioid agonist properties and little action on kappa and delta receptors, has been proven to be beneficial in preventing post-spinal shivering.
The method of action is thought to be through a modulatory influence on central monoaminergic pathways, which inhibits noradrenaline and serotonin neuronal absorption in the spinal cord while boosting hydroxyltryptamine production, resetting the body temperature regulatory center.
[3] However, it has many side effects, including nausea, vomiting, and dizziness, which add to the patient's pain.
[5] Hence research into novel solutions with adequate safety and effectiveness is strongly advised.
In this sense, despite taking into account the gold standard for post spinal shivering control is pethidine.
it is contraindicated in breastfeeding which is both legally and ethically challenging for women.
|
Tramadol intravenous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of post spinal shivering by observing grades of shivering
Time Frame: 10 minutes
|
Control of post spinal shivering Dexmedetomidine and tramadol for post spinal shivering
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Dexmedetomidine
- Tramadol
Other Study ID Numbers
- Sheikh Zayed Medical College &
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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