Clonidine Versus Granisetron for Shivering Prevension

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

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-05

Study Completion Date

2023-10-30

Brief Summary

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Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

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Detailed Description

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Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.

Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.

We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Conditions

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Post Spinal Anesthesia Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

triple blinded

Study Groups

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Group Cl (clonidine group)

will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Group Type ACTIVE_COMPARATOR

Clonidine Injection

Intervention Type DRUG

intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Group G (granisetron group)

will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Granisetron Injection

Intervention Type DRUG

intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.

Group C (control group)

will be given intravenous10ml normal saline 20 minutes before spinal anesthesia

Group Type PLACEBO_COMPARATOR

Normal Saline 10 mL Injection

Intervention Type DRUG

intravenous 10 ml normal saline 20 minutes before spinal anesthesia

Interventions

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Clonidine Injection

intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Intervention Type DRUG

Granisetron Injection

intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.

Intervention Type DRUG

Normal Saline 10 mL Injection

intravenous 10 ml normal saline 20 minutes before spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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Exclusion Criteria

History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus

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Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes