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

NCT05616364 | Unknown Phase 2

• 1 other identifier: Sheikh Zayed Medical College &
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Spinal Shivering

Outcome Measures

Primary Outcomes (1)

• Assessment of post spinal shivering by observing grades of shivering

  Control of post spinal shivering Dexmedetomidine and tramadol for post spinal shivering

  10 minutes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine injection

Tramadol

EXPERIMENTAL

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.

Drug: Tramadol

Interventions

Dexmedetomidine injection DRUG

Dexmedetomidine intravenous

Dexmedetomidine

Tramadol DRUG

Tramadol intravenous

Tramadol

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient who will give consent
• ASA 2 patients
• Female gender of age 18 to 38

You may not qualify if:

• Patient allergic to any drugs
• Uncontrolled HTN
• Antepartum
• Cardiomyopathy
• Peripartum haemorrhage
• Eclampsia
• Patients refuse to give consent

Sponsors & Collaborators

• Sana Bahadur: lead

MeSH Terms

Interventions

Dexmedetomidine; Tramadol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.Sana bahadur

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: November 15, 2022
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-11