Anti-shivering Effect of Ondansetron

Overview

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 Title of Study: “Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Study Primary Completion Date: August 15, 2018

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

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

Arms, Groups and Cohorts

• Active Comparator: normal saline
  • patients received normal saline for prevention of shivering during spinal anesthesia
• Active Comparator: ondansetron 4MG
  • patients received 4 mg of ondansetron for prevention of spinal shivering
• Active Comparator: ondansetron 8MG
  • patients received 8 mg of ondansetron for prevention of spinal shivering

Clinical Trial Outcome Measures

Primary Measures

• incidence of shivering
  • Time Frame: for 24 hours after spinal anesthesia
  • Incidence of shivering among patients in both groups

Secondary Measures

• Axillary temperature
  • Time Frame: for 24 hours after spinal anesthesia
  • patient temperature measured from axillary site
• core temperature
  • Time Frame: for 24 hours after spinal anesthesia
  • patient temperature measured from tympanic site
• incidence of hypotension
  • Time Frame: for 24 hours after spinal anesthesia
  • Incidence of hypotension between patients in both groups
• incidence of nausea and vomiting
  • Time Frame: for 24 hours after spinal anesthesia
  • Incidence of nausea and vomiting among patients in both groups

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Assiut University
• Provider of Information About this Clinical Study
  • Principal Investigator: Khaled Abdel-Baky Abdel-Rahman, lecturer – Assiut University