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Clinical Trials/CTRI/2019/03/018263
CTRI/2019/03/018263CompletedPhase 2

Randomized Double Blind Study Of Dexmedetomidine Hydrochloride And Tramadol Hydrochloride For Treatment Of Post-Spinal Anesthesia Shivering

Dr Srinitya Kollu1 site in 1 country100 target enrollmentStarted: March 26, 2019Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
COMPARE EFFICACY OF TWO DRUGS FOR CESSATION OF POST SPINAL ANAESTHESIA SHIVERING WITH LEAST SIDE EFFECTS AND BEST EFFICACY
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

PURPOSE OF THE STUDY - TO COMPARE  EFFECT OF TRAMADOL AND DEXMEDETOMIDINE ON POST SPINAL ANAESTHESIA SHIVERING

TRAMADOL IS THE DRUG ROUTINELY USED FOR TREATING SHIVERING BUT IS USUALLY ASSOCIATED WITH NAUSEA AND VOMITING. DEXMEDETOMIDINE  HAS LESSER SIDE EFFECTS AND HAS BEEN STUDIED INFERING THAT IT CAN ALSO BE USED FOR TREATMENT OF SHIVERING

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Age: Above 18yrs of age.
  • •2.American Society of Anaesthesiologists physical status I ,II, and III.
  • •3.Developed shivering after spinal anaesthesia .
  • •4.Patients who have given consent voluntarily.

Exclusion Criteria

  • •1.American society of anesthesiologists physical status IV and V.
  • •2.Patient with hepatic or renal disease, thyroid disorders,psychiatric disorders.
  • •3.Patients with history of alcohol or substance abuse.
  • •4.Hemodynamically unstable patients.
  • •5.Patients with coagulopathies, bradycardia, heart blocks, pregnant and nursing women.
  • •6.Patients unwilling to give consent for this study.

Outcomes

Primary Outcomes

COMPARE EFFICACY OF TWO DRUGS FOR CESSATION OF POST SPINAL ANAESTHESIA SHIVERING WITH LEAST SIDE EFFECTS AND BEST EFFICACY

Time Frame: FROM THE START OF SHIVERING TILL CESSATION OF SHIVERING

Secondary Outcomes

  • EFFECTS OF THE STUDY DRUGS ON HAEMODYNAMICS,SEDATION ETC(INTRAOPERATIVE AND POST-OPERATIVE PERIOD)

Investigators

Sponsor
Dr Srinitya Kollu
Sponsor Class
Other [self]

Study Sites (1)

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