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Clinical Trials/CTRI/2024/05/068112
CTRI/2024/05/068112CompletedPhase 4

Evaluation of varied doses of Intravenous Dexmedetomidine in attenuating post spinal anesthesia shivering response in patients undergoing Elective Lower Segment Cesarean Section

Kasturba Medical College, Manipal, MAHE1 site in 1 country86 target enrollmentStarted: June 9, 2024Last updated:

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

Sponsor
Kasturba Medical College, Manipal, MAHE
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Vinay Kejdiwal

Kasturba Medical College, Manipal

Study Sites (1)

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