Comparison Of Dexmedetomidine & Ketamine For Control Of Shivering In Vaginal Hysterectomy Under Spinal Anesthesia

July 29, 2022 updated by: Dr. Nida Shahid, Hamdard University

Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia

comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

Study Type

Interventional

Enrollment (Anticipated)

104

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

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients of age 45-55 years requiring vaginal hysterectomy
  2. American Society of Anesthesiology (ASA) of Grade I-II

Exclusion Criteria:

  1. Patients unwilling or non-cooperative for spinal anesthesia
  2. Patients with uncontrolled hypertension, vascular or coronary disease,
  3. patients with increased intraocular or intracranial pressure
  4. Patients with known bleeding and psychiatric disorders
  5. Patients taking anti platelets drugs.

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
Experimental: Group Dexmedetomidine
Group Dexmedetomidine receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion
Drug: Dexmedetomidine
I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion
Experimental: Group Ketamine
Group Ketamine receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion
Drug: Ketamine
0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Shivering grade
Time Frame: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively
Shivering of patients will be grouped into five grades; Grade 0: lack of shivering, Grade I: slight shivering (inconsiderable yet apparent peripheral vasoconstriction), Grade II: medium level shivering (muscular activity in one muscle group only), Grade III: severe shivering (muscular activity in more than one muscle group without generalized shivering), Grade IV: generalized shivering.
Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively

Collaborators and Investigators

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

Sponsor

Hamdard University

Investigators

  • Principal Investigator: Nida Shahid, MBBS,FCPS, Hamdard 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 (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N0331

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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