- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718011
Prevention of Shivering After Spinal Anesthesia
Comparison of Prophylactic Use of Dexmedetomidine and Ketamine for Prevention of Shivering After Spinal Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Spinal anaesthesia is a safe and popular anaesthetic technique for various surgeries. Around 40-60% of the patients under spinal anaesthesia develop shivering.The main causes of shivering intra and postoperatively are temperature loss, decreased sympathetic tone and systemic release of pyrogens. Hypothermia during neuraxial anesthesia develops initially from core to peripheral redistribution of body heat. Redistribution of body heat during spinal or epidural anesthesia typically decreases core body temperature 0.5-1.0 degree Celsius.
Shivering is characterised by involuntary oscillatory contractions of skeletal muscles. Once the body is exposed to cold, it is a physiological response for heat preservation after peripheral vasoconstriction. Postoperative shivering is defined as the fasciculation of the face, jaw or head or muscle hyperactivity, lasting longer than 15 seconds. It is a common and challenging aspect of anaesthesia and targeted temperature modulation because it leads to increase oxygen consumption and increases the risk of hypoxia.
The most frequent complication in postoperative period is shivering which is reported to be between 20-70% after general anaesthesia. The incidence reported in previous studies are 5-65% after general anaesthesia and 30-33% after epidural procedures. The overall shivering incidence in a recent meta-analysis was 34%.
The underlying pathology of shivering is not fully understood yet, therefore the definitive treatment and prevention has not been established till date. Due to its importance as postoperative complication and the lack of available data about aetiology and treatment, this narrative review of the published literature on this topic is essential.
Various pharmacological agents being used for prophylaxis and treatment of post spinal shivering are Opioids like fentanyl, tramadol, pethidine, Anticholinergics like physostigmine, NMDA receptor antagonist like ketamine and the latest being alpha-2 antagonists like clonidine, dexmedetomidine.
Recently, ketamine and dexmedetomidine have been used to prevent shivering during anaesthesia, with good results. Ketamine (a competitive NMDA receptor antagonist) plays a role in thermoregulation at various levels and ketamine, has been shown to inhibit postoperative shivering in some reports and studies.
Dexmedetomidine, a centrally acting alpha 2-adrenergic agonist, has been used as a sedative agent and is known to reduce the shivering threshold. Dexmedetomidine also provided sedation which is sufficient to prevent the anxiety without any adverse effects. And until date, there are limited studies using dexmedetomidine in the treatment of postoperative shivering.
A very limited data is available on this subject in our Pakistani population. Pethidine is drug of choice for the prevention and treatment of shivering. Due to the non-availability of Pethidine, doctors are looking for newer and better options. Considering this, a study is designed to compare between Dexmedetomidine and Ketamine, as they are easily available and very few studies are done till date comparing them, as ketamine isn't researched much as an anti-shivering agent as it is known for undesirable side effects like delirium and hallucinations and dexmedetomidine being a newer agent. Results of this study will help to select the better prophylactic option for prevention of shivering after spinal anaesthesia in our general population.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44230
- PAF Hospital Islamabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 20-50 years.
- Both genders
- ASA physical status I and II
- Undergoing lower abdominal or lower limb surgeries under spinal anaesthesia
Exclusion Criteria:
- Patients with history of thyroid and neuromuscular diseases
- Patients with severe hypovolemia
- Patients with febrile illness
- Patients who required blood transfusion during surgery
- Patients with body temperature ≤ 36˚C or ≥ 38˚C on thermometer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: dexmedetomidine
0.5 micrograms/kg
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0.5 micrograms/kg diluted in 10mL of normal saline 0.9% given as IV infusion over 10 minutes
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ACTIVE_COMPARATOR: ketamine
0.5 milligram/kg
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0.5 milligrams/kg diluted in 10mL of normal saline 0.9% given as IV infusion over 10 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Shivering
Time Frame: Change in every 10 minutes after spinal anesthesia till PACU discharge after 01 hour PACU stay.
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Visible muscle activity in more than one muscle group.
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Change in every 10 minutes after spinal anesthesia till PACU discharge after 01 hour PACU stay.
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Collaborators and Investigators
Investigators
- Principal Investigator: ATIYA CHAUDHRY, MBBS, PAF Hospital Islamabad
Publications and helpful links
General Publications
- Bindu B, Bindra A, Rath G. Temperature management under general anesthesia: Compulsion or option. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):306-316. doi: 10.4103/joacp.JOACP_334_16.
- Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1.
- Choi KE, Park B, Moheet AM, Rosen A, Lahiri S, Rosengart A. Systematic Quality Assessment of Published Antishivering Protocols. Anesth Analg. 2017 May;124(5):1539-1546. doi: 10.1213/ANE.0000000000001571.
- Park SM, Mangat HS, Berger K, Rosengart AJ. Efficacy spectrum of antishivering medications: meta-analysis of randomized controlled trials. Crit Care Med. 2012 Nov;40(11):3070-82. doi: 10.1097/CCM.0b013e31825b931e.
- Leite MA, Orsini M, de Freitas MR, Pereira JS, Gobbi FH, Bastos VH, de Castro Machado D, Machado S, Arrias-Carrion O, de Souza JA, Oliveira AB. Another Perspective on Fasciculations: When is it not Caused by the Classic form of Amyotrophic Lateral Sclerosis or Progressive Spinal Atrophy? Neurol Int. 2014 Aug 8;6(3):5208. doi: 10.4081/ni.2014.5208. eCollection 2014 Aug 5.
- Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. doi: 10.1093/bja/84.5.615. No abstract available.
- Bozgeyik S, Mizrak A, Kilic E, Yendi F, Ugur BK. The effects of preemptive tramadol and dexmedetomidine on shivering during arthroscopy. Saudi J Anaesth. 2014 Apr;8(2):238-43. doi: 10.4103/1658-354X.130729.
- Lakhe G, Adhikari KM, Khatri K, Maharjan A, Bajracharya A, Khanal H. Prevention of Shivering during Spinal Anesthesia: Comparison between Tramadol, Ketamine and Ondansetron. JNMA J Nepal Med Assoc. 2017 Oct-Dec;56(208):395-400.
- Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Ketamine
- Dexmedetomidine
Other Study ID Numbers
- PAFHIslamabad2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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