Anti-shivering Effect of Ondansetron

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/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2018-09-15

Brief Summary

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Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

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Detailed Description

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Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Conditions

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Shivering Ondansetron

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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normal saline

patients received normal saline for prevention of shivering during spinal anesthesia

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

normal saline used for prevention of spinal shivering

ondansetron 4MG

patients received 4 mg of ondansetron for prevention of spinal shivering

Group Type ACTIVE_COMPARATOR

Ondansetron 4 MG

Intervention Type DRUG

ondansetron 4 MG used for prevention of spinal shivering

ondansetron 8MG

patients received 8 mg of ondansetron for prevention of spinal shivering

Group Type ACTIVE_COMPARATOR

Ondansetron 8mg

Intervention Type DRUG

ondansetron 8 MG used for prevention of spinal shivering

Interventions

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Normal saline

normal saline used for prevention of spinal shivering

Intervention Type DRUG

Ondansetron 4 MG

ondansetron 4 MG used for prevention of spinal shivering

Intervention Type DRUG

Ondansetron 8mg

ondansetron 8 MG used for prevention of spinal shivering

Intervention Type DRUG

Other Intervention Names

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placebo low ondansetron high ondansetron

Eligibility Criteria

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Inclusion Criteria

* Age between 18-65 years
* Both sexes
* American Society of Anesthesiologists
* physical status I and II
* scheduled for lower limb surgery under spinal anesthesia

Exclusion Criteria

* Uncooperative patients
* psychologically unstable patients
* obese patients with BMI \>30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No