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

Phase 3

• Conditions: Chills
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT05481281
• Lead Sponsor: Hamdard University

Brief Summary

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

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 Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study Start: 2022-08-01
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Dexmedetomidine	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
Group Ketamine	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

Primary Outcome Measures

Name	Time	Method
Change in Shivering grade	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.