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

NCT06091657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-01-17

No results posted yet for this study

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.

Conditions

  • Intraoperative Shivering
  • Ketamine With Shivering
  • Dexamethasone for Shivering
  • Severe Shivering

Interventions

DRUG

Ketamine Hydrochloride

intravenous injection

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-15
Completion
2024-07-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091657 on ClinicalTrials.gov