ShiveringPhase 4NCT03302351
Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia
A Phase 4 study testing Dexmedetomidine, ketamine and Dexmetedomidine+Ketamine in people with Shivering, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shivering
- What is being tested?
- Dexmedetomidine, ketamine and Dexmetedomidine+Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination to Control Shivering During Regional Anaethesia
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.
Read the 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
- Being tested
- Dexmedetomidine, ketamine, Dexmetedomidine+Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
30 patients will receive intravenous dexmedetomidine 1 mcg/kg.
ketamineDrug
Also called katalar
31 patients will receive intravenous ketamine 0.4 mg/kg.
Dexmetedomidine+KetamineDrug
Also called precedex+katalar
33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 1st group will include 30 patients will receive intravenous dexmedetomidine 1 mcg/kg. Receives: Drug: Dexmedetomidine |
| Ketamine | Experimental | 2nd group will include 31 patients will receive intravenous ketamine 0.4 mg/kg. Receives: Drug: ketamine |
| Dexmetedomidine-Ketamine combination | Experimental | 3rd group will include 33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg and low dose ketamine 0.25mg/kg. Receives: Drug: Dexmetedomidine+Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
shivering score
p1(frequency of number)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302351
- Sponsor's protocol ID
- AMMH
- Status last verified
- Jul 2018
- First submitted
- 26 Sep 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nikolic K, Popovic R. Conductometric determination of periciazine. Acta Pol Pharm. 1978;35(2):195-9. No abstract available.
PubMed 27062
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination to Control Shivering During Regional Anaethesia
- ClinicalTrials.gov ID
- NCT03302351
- Acronym / sponsor ID
- AMMH
- Conditions
- Shivering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine1st group will include 30 patients will receive intravenous dexmedetomidine 1 mcg/kg. |
| Ketamine | Experimental | Drug: ketamine2nd group will include 31 patients will receive intravenous ketamine 0.4 mg/kg. |
| Dexmetedomidine-Ketamine combination | Experimental | Drug: Dexmetedomidine+Ketamine3rd group will include 33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg and low dose ketamine 0.25mg/kg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: precedex30 patients will receive intravenous dexmedetomidine 1 mcg/kg. | Drug | Dexmedetomidine |
| ketamineAlso: katalar31 patients will receive intravenous ketamine 0.4 mg/kg. | Drug | Ketamine |
| Dexmetedomidine+KetamineAlso: precedex+katalar33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg. | Drug | Dexmetedomidine-Ketamine combination |
Primary outcome
shivering score
Time frame: 10 minutes
p1(frequency of number)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 27062Nikolic K, Popovic R. Conductometric determination of periciazine. Acta Pol Pharm. 1978;35(2):195-9. No abstract available.
Related trials for Shivering
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, ketamine and Dexmetedomidine+Ketamine in people with Shivering, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shivering score (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.