Skip to content

Anti-shivering Effect of Ondansetron

Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03530007
Enrollment
120
Registered
2018-05-21
Start date
2018-05-15
Completion date
2018-09-15
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shivering, Ondansetron

Brief summary

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

Detailed description

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.

Interventions

DRUGNormal saline

normal saline used for prevention of spinal shivering

ondansetron 4 MG used for prevention of spinal shivering

ondansetron 8 MG used for prevention of spinal shivering

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of shiveringfor 24 hours after spinal anesthesiaIncidence of shivering among patients in both groups

Secondary

MeasureTime frameDescription
incidence of hypotensionfor 24 hours after spinal anesthesiaIncidence of hypotension between patients in both groups
incidence of nausea and vomitingfor 24 hours after spinal anesthesiaIncidence of nausea and vomiting among patients in both groups
Axillary temperaturefor 24 hours after spinal anesthesiapatient temperature measured from axillary site
core temperaturefor 24 hours after spinal anesthesiapatient temperature measured from tympanic site

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026