Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia
Comparing Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination to Control Shivering During Regional Anaethesia
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJuly 3, 2018
July 1, 2018
5 months
September 26, 2017
July 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
shivering score
p1(frequency of number)
10 minutes
Study Arms (3)
Dexmedetomidine
EXPERIMENTAL1st group will include 30 patients will receive intravenous dexmedetomidine 1 mcg/kg.
Ketamine
EXPERIMENTAL2nd group will include 31 patients will receive intravenous ketamine 0.4 mg/kg.
Dexmetedomidine-Ketamine combination
EXPERIMENTAL3rd group will include 33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg and low dose ketamine 0.25mg/kg.
Interventions
30 patients will receive intravenous dexmedetomidine 1 mcg/kg.
33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ghada Mohammmad Aboalfadl
Asyut, Egypt
Related Publications (1)
Nikolic K, Popovic R. Conductometric determination of periciazine. Acta Pol Pharm. 1978;35(2):195-9. No abstract available.
PMID: 27062BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2017
First Posted
October 5, 2017
Study Start
October 1, 2017
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
July 3, 2018
Record last verified: 2018-07