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

NCT ID: NCT03302351

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-04-01

Brief 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.

Conditions

Shivering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

1st group will include 30 patients will receive intravenous dexmedetomidine 1 mcg/kg.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

30 patients will receive intravenous dexmedetomidine 1 mcg/kg.

Ketamine

2nd group will include 31 patients will receive intravenous ketamine 0.4 mg/kg.

Group Type: EXPERIMENTAL

ketamine

Intervention Type: DRUG

31 patients will receive intravenous ketamine 0.4 mg/kg.

Dexmetedomidine-Ketamine combination

3rd group will include 33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg and low dose ketamine 0.25mg/kg.

Group Type: EXPERIMENTAL

Dexmetedomidine+Ketamine

Intervention Type: DRUG

33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.

Interventions

Dexmedetomidine

30 patients will receive intravenous dexmedetomidine 1 mcg/kg.

Intervention Type: DRUG

ketamine

31 patients will receive intravenous ketamine 0.4 mg/kg.

Intervention Type: DRUG

Dexmetedomidine+Ketamine

33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.

Intervention Type: DRUG

Other Intervention Names

precedex; katalar; precedex+katalar

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ghada Mohammmad Aboalfadl

Asyut, , Egypt

Countries

Egypt

References

Nikolic K, Popovic R. Conductometric determination of periciazine. Acta Pol Pharm. 1978;35(2):195-9. No abstract available.

Reference Type: BACKGROUND

PMID: 27062 (View on PubMed)

Other Identifiers

AMMH

Identifier Type: -

Identifier Source: org_study_id