Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering

December 3, 2024 updated by: Nazish Kanwal, Liaquat National Hospital & Medical College

Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial

*Ketamine:* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

- *Tramadol:* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

  • Reduced discomfort and anxiety for the patient
  • Improved patient satisfaction
  • Reduced need for additional medications or interventions
  • Faster recovery times

Study Type

Interventional

Enrollment (Estimated)

250

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

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Liaquat National Hospital and Medical College
        • Principal Investigator:
          • Nazish kanwal Dr Nazish Kanwal
        • Contact:
        • Contact:
      • Karachi, Sindh, Pakistan, 75500
        • Recruiting
        • Liaquat National Hospital and Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nazish kanwal Dr Nazish Kanwal

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pateint for elective cesarean section
  • Age 18 to 40 years
  • ASA 1 and 2

Exclusion Criteria:

  • ASA 2 and 3
  • Cesarean section requiring general anesthesia
  • Hypersensitivity to Ketamine, Tramadol and Opiods
  • History of cardiovascular disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group K
Group K receive Inj: ketamine
Drug: Ketamine only
Inj: Ketamine given to group K following spinal anesthesia
Active Comparator: Group T
Group T receive Inj: Tramadol
Drug: Tramadol
Inj Tramadol given to group T following spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering
Time Frame: 20 minutes to 12 hours
Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body
20 minutes to 12 hours

Collaborators and Investigators

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

Sponsor

Liaquat National Hospital & Medical College

Investigators

  • Principal Investigator: Nazish Dr Nazish Kanwal, Liaquat National Hospital and Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

September 30, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #882-2023-LNH-ERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient confidentiality*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families.

  • Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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