Anti-shivering Effect of Ondansetron

Shivering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03530007
• Other study ID #: IRB00008718/3167
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: May 15, 2018
• Est. completion date: September 15, 2018

Study information

• Verified date: May 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ondansetron
• Shivering

Intervention

Drug:
• Normal saline
normal saline used for prevention of spinal shivering
• Ondansetron 4 MG
ondansetron 4 MG used for prevention of spinal shivering
• Ondansetron 8mg
ondansetron 8 MG used for prevention of spinal shivering

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of shivering	Incidence of shivering among patients in both groups	for 24 hours after spinal anesthesia
Secondary	Axillary temperature	patient temperature measured from axillary site	for 24 hours after spinal anesthesia
Secondary	core temperature	patient temperature measured from tympanic site	for 24 hours after spinal anesthesia
Secondary	incidence of hypotension	Incidence of hypotension between patients in both groups	for 24 hours after spinal anesthesia
Secondary	incidence of nausea and vomiting	Incidence of nausea and vomiting among patients in both groups	for 24 hours after spinal anesthesia