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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to either 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) OR 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) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block.

In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

the drugs will be prepared by anesthesiologist who will not be the part of the study and these drugs will be injected by another anesthesiologist who will be blinded to the drugs and will be participating into the study.

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion

Interventions

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Dexmedetomidine

I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion

Intervention Type DRUG

Ketamine

0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes