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

April 4, 2022 updated by: Obaid ur Rehman, Sheikh Zayed Medical College

Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section

To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

71

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine
Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
Drug: Dexmedetomidine
Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.
EXPERIMENTAL: Ketamine
Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
Drug: Ketamine
Ketamine
EXPERIMENTAL: Tramadol
Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes
Drug: Tramadol
Tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 30, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

February 20, 2023

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (ACTUAL)

April 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORehman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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