Preventive effect of intravenous Ondansetron and Paracetamol on shivering after spinal anesthesia in cesarean section

Preventive effect of intravenous ondansetron and paracetamol on shivering after spinal anesthesia

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 99 patients. Random allocation software was used for randomization.

This study will be conducted in Shariati Bandar Abbas Hospital in 2024 after the approval of the thesis and university ethics committee as a blind prospective clinical trial study on 99 patients aged 18 to 45 candidates for elective cesarean section. The participants were simple randomized construction and divided into three groups using random allocation software. The first group receives 15 mg/kg of Apotel (maximum dose1000 mg) in 100 cc of normal saline within 5 minutes before Spinal anesthesia. The second group receives 4 mg ondansetron in 100 cc of normal saline within 5 minutes before spinal anesthesia.The third group receives 100 cc of normal saline during the same time before spinal anesthesia. During surgery and recovery, the degree of shivering, pain, nausea and vomiting will measured by a trained intelligence expert who does not know about the classification of patients.

Inclusion: aged 18-45 with ASA I, II are candidates for elective caesarean section with spinal anesthesia، gestational age ≥ 37 weeks .exclusion: contraindications, such as: high ICP, coagulation disorders, drug allergies, emergency cesarean section

Three groups: First group: recipient of 15 mg per kilogram of Apotel in 100 cc of normal salineThe second group: receiving 4 mg of ondansetron in 100 cc of normal salineThe third group: receiving 100 cc of normal saline (control group)

Study variables: Pain intensity, chills, type of medicine, nausea and vomiting, amount of painkillers, blood pressure, heart rate, anti-chilling medicine

Randomly and using Random Allocation software A third person who has no role in the implementation of the project, prepares medicine packs anonymously with a code, the name of the drug is unknown, and the preparation is done by the third person and is given to the intelligence expert. The expert randomly chooses from among the envelopes and injects without knowing the patient's condition, He only checks the vital signs. The selection of the intelligence expert is done completely randomly without prior knowledge of the details of the work. The code numbers of the drugs are given to the third party by statistician of the project.

Regarding the method of blinding, the project managers are completely blind in choosing the type of medicine and the patient. A third person who has no role in the project is informed by the project statistician about the type of drugs used and the dosage, and the drugs are prepared in completely secret packs. and makes it available to the intelligence expert only through the codes that the person knows what the medicine is. The expert randomly selects the pregnant mother without prior knowledge of the condition of the pregnant mother, who was previously rejected from the entry and exit criteria filter, and completely randomly. He selects and injects a drug pack from the previously prepared packs, then records the patient's vital signs at known times according to the checklist, experts are also randomly selected every day.