Anti-shivering Effect of Ondansetron

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Shivering; Ondansetron

Treatments: Drug: Normal saline; Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03530007

IRB00008718/3167

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 3 patient groups

normal saline

Active Comparator group

Description:

patients received normal saline for prevention of shivering during spinal anesthesia

Treatment:

Drug: Normal saline

ondansetron 4MG

Active Comparator group

Description:

patients received 4 mg of ondansetron for prevention of spinal shivering

Treatment:

Drug: Ondansetron 4 MG

ondansetron 8MG

Active Comparator group

Description:

patients received 8 mg of ondansetron for prevention of spinal shivering

Treatment:

Drug: Ondansetron 8mg