Comparison of Ketamine Plus Dexamethasone Versus Ketamine Alone for Prevention of Severe Shivering After Spinal Anesthesia in Cesarean Section

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Shivering is one of the most distressing events of the birth experience for patients. Shivering that occurs with spinal anesthesia is a frequent event, with a reported incidence of up to 50-65%. (1) This may be normal thermoregulatory shivering in response to core hypothermia or may result from the release of cytokines by the surgical procedure. (2-4) shivering is graded with a scale described by Bedside Shivering Assessment Score (BSAS). (3, 4) Most of the literature recommends a variety of non-pharmacological and pharmacological options for the prevention and treatment of shivering after spinal anesthesia. Pethidine, tramadol, clonidine, dexmedetomidine, biogenic amines (serotonin 5-HT3 receptor antagonist), low-dose ketamine, dexamethasone, and magnesium sulfate were used as pharmacological agents. (5) Intravenous (IV) ketamine 0.25 mg/kg was approved as effective in the prevention and treatment of shivering after regional anesthesia and can be used in patients undergoing cesarean sections without adverse effects on the baby. (5) Ketamine is a competitive N-methyl-D-aspartate receptor antagonist, and it is believed that its anti-shivering action is due to non-shivering thermogenesis, either by effect on the hypothalamus or by the β-adrenergic effect of norepinephrine. (6) In spite of the approved effectiveness of ketamine in this issue, moderate to severe shivering (grade ≥ 2) still occurs with an incidence that cannot be ignored. (7-9) Dexamethasone was also approved as an alternative pharmacological agent for the prevention and treatment of mild and moderate shivering. (10) Dexamethasone prevents shivering by regulating immune response and decreasing the temperature gradient between skin and body core via its anti-inflammatory action and inhibition of the release of vasoconstrictors and pyrogenic cytokines. We hypothesize that addition of dexamethasone (0.1 mg\kg) to low dose ketamine (0.25 mg\kg) will be more effective in prevention of severe shivering after spinal anesthesia with cesarean section with minimal sedation of the mother and negligible effect on the baby. This can be applicable in resource-limited settings.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kasr El Aini Hospital
• Treatments: Dexamethasone; Ketamine

Criteria

Inclusion Criteria:

• 1. Inclusion criteria

• pregnant females

• aged 18 to 45 years

• ASA physical status II

• elective Cesarean sections under spinal anesthesia 2. Exclusion criteria

• Contraindications for spinal anesthesia

• Emergency cesarean sections

• Patient with initial body temperature >38°c or <36°c

• Allergy to any of the drugs used in the study

• Pre Existing neurological diseases (particularly those that wax and wane, e.g.multiple sclerosis)

• Thrombocytopenia and coagulation disorders.

• Severe stenotic heart disease.

Exclusion Criteria:

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