Compair Efficacy of iv Dexmedetomidine & Tramadol for Post Spinal Shivering in Obs Patients Undergoing Cesarean Section

NCT ID: NCT05616364

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-02-28

Brief Summary

When opposed to GA,SA is recommended during c section. Shivering is more prevalent and inconvenient complication of spinal anaesthesia, with 40 to 70% incidence rate. Tramadol has been proven to be beneficial in preventing post spinal shivering. Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic and opioid-sparing alpha adrenergic agonist. It has been shown to lower the threshold for shivering. The study aims to search for best drug for blunting shivering response.

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.

Conditions

Post Spinal Shivering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dexmedetomidine injection

Intervention Type: DRUG

Dexmedetomidine intravenous

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.

Group Type: EXPERIMENTAL

Tramadol

Intervention Type: DRUG

Tramadol intravenous

Interventions

Dexmedetomidine injection

Dexmedetomidine intravenous

Intervention Type: DRUG

Tramadol

Tramadol intravenous

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sana Bahadur

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sana Bahadur

Dr.Sana bahadur

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Sheikh Zayed Medical College &

Identifier Type: -

Identifier Source: org_study_id