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Clinical Trials/CTRI/2025/02/080845
CTRI/2025/02/080845Not yet recruitingNot Applicable

Effect of subcutaneous dexmedetomidine in reducing shivering following cesarean section: a randomized control study.

All India Institute of Medical Sciences Patna1 site in 1 country68 target enrollmentStarted: February 21, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
68
Locations
1
Primary Endpoint
Incidence and severity of shivering using patient rated 10 points VAS score after cesarean delivery
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Previous studies documented that even though intravenous dexmedetomidine reduces the incidence of shivering, intravenousdexmedetomidine requires close monitoring, infusion pump and may be associated with adverse effects like Bradycardia, Hypotension and AV block.On injecting dexmedetomidine via subcutaneous route, it will allow its slow action and reduces complications rate in comparison to its intravenous injection.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
25.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •American Society of Anaesthesiologists physical status 2, Scheduled for Cesarean delivery under spinal anaesthesia.

Exclusion Criteria

  • •Pre-existing structural heart diseases Eclampsia Preeclampsia Cesarean under general anesthesia Psychiatric patient History of convulsions Patients received opioids/ tramadol for shivering management during intraoperative and postoperative periods Patient underwent resurgery.

Outcomes

Primary Outcomes

Incidence and severity of shivering using patient rated 10 points VAS score after cesarean delivery

Time Frame: At 30 minutes of postoperative period.

Secondary Outcomes

  • Incidence and severity using Observer Rated 5 point Likert Scale(At 30 minutes, 4 hours, 8 hours, 12 hours)
  • Post operative pain using NRS score(At 30 minutes, 4 hours, 8 hours, 12 hours)

Investigators

Sponsor
All India Institute of Medical Sciences Patna
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Amarjeet Kumar

All India Institute of Medical Sciences Patna

Study Sites (1)

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