Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section

November 15, 2023 updated by: Dr Muhammad Arif, Ziauddin University

Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section

The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 4

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 Locations

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:

  • Age between 18 to 40 years
  • American Society of Anesthesiologist physical status I and II
  • Pregnant female for lower segment caeserian section

Exclusion Criteria:

  • Patients with Hypertension
  • Patients with hypo- or hyperthyroidism
  • Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
  • An initial body temperature 38.00C or, 36.0oC assessed by thermometer

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol with Ketamine
Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg
Drug: Tramadol with Ketamine
Tramadol with Ketamine is being provided randomly using prospective, double-blind
Active Comparator: Tramadol
Tramadol 0.5mg/kg
Drug: Tramadol
Tramadol alone is being provided randomly using prospective, double-blind

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of shivering
Time Frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering
Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Severity of Shivering
Time Frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

Shivering will be graded as per the following criteria:

0= no shivering.

  1. piloerection or peripheral vasoconstriction but no visible shivering.
  2. muscular activity (visible muscular twitching) in only one muscle group;
  3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized.
  4. shivering involving the whole body
Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to shivering
Time Frame: 15 mins from the administration of the prophylactic drug
The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering.
15 mins from the administration of the prophylactic drug
Complications
Time Frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted
Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

Collaborators and Investigators

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

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Muhammad Arif, Ziauddin University

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)

August 16, 2023

Primary Completion (Estimated)

November 16, 2023

Study Completion (Estimated)

November 16, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240623MAANE

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

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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