Comparison of the effectiveness of Ketamine, Tramadol and Ondansetron on prevention of shivering due to Spinal Anesthesia in cesarean section surgery

Introduction and utilization of an effective, uncomplicated method and suitable replacement for pethidine to control shivering in spinal anesthesia in cesarean section

A double-blinded and randomized clinical trial with parallel groups design of 508 patients

This study will be done as a clinical trial in Alzahra Hospital in Rasht. All patients will have at least 8 hours of fasting. Before performing anesthesia, hemodynamic variables, operating room temperature, and central temperature of patients will be recorded. Spinal anesthesia will be performed with 12.5 milligrams isobar marcaine on lumbar spine 3 and 4. If despite receiving these medications, patients experience shivering in Grades 3 and 4, they will receive 25 milligrams pethidine after clamping the cord. Cases of repeated shivering, cases that receive pethidine, the intensity of postoperative shivering and minute one and five Apgar score of babies will be recorded. In this study, the intensity of shivering will be recorded every 5 minutes during operation time and every 15 minutes in 45 minutes of recovery time(3 times). Drugs will be prepared and coded by an anesthetic technician, not included in the research. Patients, the responsible anesthetist, and the person who records signs are blind.

Entry criteria: pregnant women candidate for cesarean section under spinal anesthesia, ASA Class I, II and, age 18-39 Non-entry criteria: a history of allergy or prohibition for each of studied drugs, addiction, heart disease, liver, and kidney dysfunction.

ketamine group (0.2 milligrams per kilogram intravenous), tramadol group (0.5 milligrams per kilogram intravenous), Ondansetron group (4 milligrams intravenous), control group (5 milliliters normal saline)

Shivering intensity based on the used drug, Apgar minute one and five

Patients will be randomized with quadruple blocks and divide into four groups of a low dose of ketamine=A, tramadol=B, Ondansetron=C, and control=D. The randomization unit is individual. In this randomization, we do not have a layer and we use a random numbers table tool. The method of constructing a random sequence is as follows: ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA--CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA--CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD After providing the list, we will give it to the anesthetic technician to categorize patients in control or treatment groups based on the above list.

All drugs and placebo (normal saline) are prepared by an anesthetic technician who is not included in this study and will be coded in 5-millimeter syringes and will be given to the responsible anesthetist. So, In the event of complications (drowsiness, nausea, vomiting, itching, flushing, and hallucination), it will be clear which patient belongs to which Group and if necessary, it will be treated based on the type of complication. Accordingly, patients, the anesthetist, and the trained person recording items listed in the questionnaire (severity of shivering, Apgar minute one and five and vital signs of patients) are unaware of the type of treatment group.