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

Chills Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05481281
• Other study ID #: N0331
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2022
• Source: Hamdard University
• Contact: Nida Shahid, MBBS, FCPS
• Phone: +923332358698
• Email: nida-shahid2011[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: January 31, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chills

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shivering grade	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