Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia
Condition: Shivering
Study type: Interventional
Phase: Phase 4

Summary: 
      Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The
      incidence of shivering has been found to be quite high, approximately 40-50% in different
      studies. It can double or even triple oxygen consumption and carbon dioxide production.
      Shivering also increase intraocular and intracranial pressure, and may contribute to
      increased wound pain, delayed wound healing, and delayed discharge from post-anaesthetic
      care. Apart from being an uncomfortable experience, its deleterious effects deserve primary
      prevention and rapid control on occurence.
    

Detailed description: 
      Shivering is a physiological response to core hypothermia in an attempt to raise the
      metabolic heat production. The main causes of intra and postoperative shivering are heat
      loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anaesthesia
      significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which
      plays a significant role in temperature regulation. It also causes a redistribution of core
      heat from the trunk (below the block level) to the peripheral tissues. These factors
      predispose patients to hypothermia and shivering.

      The treatment of shivering includes both pharmacological and non-pharmacological methods. The
      non-pharmacological management is by external heating like the use of forced air warming,
      warming blankets, warmed fluids etc.

      According to the results of meta-analysis, the most frequently reported pharmacological
      interventions include clonidine, pethidine, tramadol, nefopam, and ketamine. Unfortunately,
      no gold standard treatment is known for shivering as the administration of all the available
      drugs is associated with various adverse effects.

      Dexmedetomidine, a congener of clonidine, is a highly selective adrenoceptor agonist. It has
      been used as a sedative agent and is known to reduce the shivering threshold. Few studies
      which have explored its anti-shivering potential have inferred that dexmedetomidine is an
      effective drug without any major adverse effect and provides good haemodynamic stability.

      Ketamine has been tried to prevent shivering during anaesthesia with good results. Ketamine a
      competitive NMDA receptor antagonist has a role in thermoregulation at various levels. NMDA
      receptor modulates non-adrenergic and serotoninergic neurons in locus coeruleus. It is used
      as anti-shivering agent.

      Shivering is a physiological response to core hypothermia in an attempt to raise the
      metabolic heat production. The main causes of intra and postoperative shivering are heat
      loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anaesthesia
      significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which
      plays a significant role in temperature regulation. It also causes a redistribution of core
      heat from the trunk (below the block level) to the peripheral tissues. These factors
      predispose patients to hypothermia and shivering.

      The treatment of shivering includes both pharmacological and non-pharmacological methods. The
      non-pharmacological management is by external heating like the use of forced air warming,
      warming blankets, warmed fluids etc.

      According to the results of meta-analysis, the most frequently reported pharmacological
      interventions include clonidine, pethidine, tramadol, nefopam, and ketamine. Unfortunately,
      no gold standard treatment is known for shivering as the administration of all the available
      drugs is associated with various adverse effects.

      Dexmedetomidine, a congener of clonidine, is a highly selective adrenoceptor agonist. It has
      been used as a sedative agent and is known to reduce the shivering threshold. Few studies
      which have explored its anti-shivering potential have inferred that dexmedetomidine is an
      effective drug without any major adverse effect and provides good haemodynamic stability.

      Ketamine has been tried to prevent shivering during anaesthesia with good results. Ketamine a
      competitive NMDA receptor antagonist has a role in thermoregulation at various levels. NMDA
      receptor modulates non-adrenergic and serotoninergic neurons in locus coeruleus. It is used
      as anti-shivering agent.
    

Intervention name(s): Dexmedetomidine; ketamine; Dexmetedomidine+Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 patients will receive intravenous dexmedetomidine 1 mcg/kg.; 31 patients will receive intravenous ketamine 0.4 mg/kg.; 33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.
Other intervention name(s): precedex; katalar; precedex+katalar
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment