Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia

Shivering Clinical Trial

Official title:

Comparing Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination to Control Shivering During Regional Anaethesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302351
• Other study ID #: AMMH
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• This study will include adults between 18 and 60 years of age undergo elective lower abdominal and lower limb surgery using spinal anaesthesia.

• ASA grade I - II

Exclusion Criteria:

• Patient refusal.

• Patients who have temperature over 37.3 or below 36 celsius degree.

• Known allergies to the study drugs.

• Contraindication to spinal anaesthesia as coagulopathy,

• patients with thyroid disease, Parkinson disease, dysautonomia, Raynaud syndrome, use of sedative-hypnotic agent or vasodilators.

Related Conditions & MeSH terms

• Shivering

Intervention

Drug:
• Dexmedetomidine
30 patients will receive intravenous dexmedetomidine 1 mcg/kg.
• ketamine
31 patients will receive intravenous ketamine 0.4 mg/kg.
• Dexmetedomidine+Ketamine
33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.

Locations

Country	Name	City	State
Egypt	Ghada Mohammmad Aboalfadl	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Nikolic K, Popovic R. Conductometric determination of periciazine. Acta Pol Pharm. 1978;35(2):195-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shivering score	p1(frequency of number)	10 minutes