Evaluation of varied doses of Intravenous Dexmedetomidine in attenuating post spinal anesthesia shivering response in patients undergoing Elective Lower Segment Cesarean Section
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Shivering score will be measured according to crossley and mahajan grading for shivering
Study Overview
Brief Summary
Shivering during Cesarean delivery under neuraxial anesthesia occurs frequently and can be very distressing. Its origin is both thermogenic and non-thermogenic. Internal redistribution of core temperature, loss of thermoregulatory vasoconstriction below the level of blockade, and a decrease of the vasoconstriction threshold are possible explanations for shivering under neuraxial anesthesia. Active warming methods, such as forced air blankets, are an intuitive and attractive solution to such a problem; nevertheless, studies regarding their effectiveness in the context of parturient undergoing Cesarean delivery have been conflicting and do not address the complex pathophysiology of shivering.
This study involves the use of drug dexmedetomidine and has been approved by FDA for intravenous use purpose. Through its action on the alpha 2b-adrenoceptor in the hypothalamus, dexmedetomidine suppresses spontaneous firing rate of neurons, decreases central thermosensitivity, and reduces vasoconstriction and shivering thresholds. Two different doses will be compared in terms of time required for observable decrease in shivering caused by central neuraxial block in LSCS patients. Along with shivering, sedation and incidence of adverse events such as nausea, vomiting and respiratory depression will also be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA physical status 2 patients above 18 years of age who shiver during elective LSCS that continued to cord clamping.
Exclusion Criteria
- •Unscheduled caesarean deliveries History of chronic nausea or itching in pregnancy Chronic opioid use History of cardiac, renal or hepatic disease requiring follow up or medications Coagulation disorders History of febrile illness.
Outcomes
Primary Outcomes
Shivering score will be measured according to crossley and mahajan grading for shivering
Time Frame: At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes
Secondary Outcomes
- Sedation score(At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes)
Investigators
Dr Vinay Kejdiwal
Kasturba Medical College, Manipal
