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Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.

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ClinicalTrials.gov Identifier: NCT05311722
Recruitment Status : Not yet recruiting
First Posted : April 5, 2022
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Obaid ur Rehman, Sheikh Zayed Medical College

Tracking Information
First Submitted Date  ICMJE March 9, 2022
First Posted Date  ICMJE April 5, 2022
Last Update Posted Date April 5, 2022
Estimated Study Start Date  ICMJE April 30, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2022)
Assessment of post spinal shivering by observing grades of shivering [ Time Frame: 10 minutes ]
Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.
Official Title  ICMJE Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section
Brief Summary To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine
Detailed Description Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3 drugs were given to patients
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Post-Surgical Complication
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.
  • Drug: Ketamine
    Ketamine
  • Drug: Tramadol
    Tramadol
Study Arms  ICMJE
  • Experimental: Dexmedetomidine
    Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
    Intervention: Drug: Dexmedetomidine
  • Experimental: Ketamine
    Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
    Intervention: Drug: Ketamine
  • Experimental: Tramadol
    Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
    Intervention: Drug: Tramadol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2022)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Woman of age 18-60
  • Pregnant woman in outdoor patient department and emergency

Exclusion Criteria:

  • patient. with history of hypersensitivity to opioids,
  • ketamine or bupivacaine
  • History of cardiovascular disease,
  • Hypertension,
  • psychosis,
  • antepartum hemorrhage,
  • cord prolapse,
  • fetal distress
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: All females with age between 18 -60
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Obaid ur rehman Reman, Mbbs 03335817980 drobaid_55@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05311722
Other Study ID Numbers  ICMJE ORehman
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Obaid ur Rehman, Sheikh Zayed Medical College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheikh Zayed Medical College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheikh Zayed Medical College
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP