The effect of oral Tramadol in prevention and treatment of Intra & post-operative shivering in inguinal surgery by spinal anesthesia

Evaluation of the efficacy of oral tramadol in preventing shivering as an complication of the anesthesia, before and during elective surgery.

The clinical trial has two groups. All patients are candidates for elective inguinal surgery with spinal anesthesia. The study is phase 3. 200 patients will be selected and divided into intervention and comparison group of 100. This is a double blinded study and SPSS was used for randomization.

The study site is Ayatollah Rouhani Hospital in Babol. The study is performed in the way of oral medication or placebo, two hours before surgery, then patients' clinical response during and after surgery will be collected and recorded in forms. The researcher and clinical caregiver are blinded. Contents and packaging of a medicine or placebo similar in shape, color, size, and can only be identified to statistician by random four-digit numbers.

Inclusion criteria: Age range 18 to 70 years Classes one and two ASA Elective surgery Inguinal surgery Spinal anesthesia No drug addiction Exclusion criteria: Patient dissatisfaction with spinal anesthesia ASA class three or more Emergency surgery Drug addiction Recent history of nausea and vomiting History of respiratory depression

Two hours before the operation, each patient given a 50 mg tramadol tablet (case group) with 150 cc of water or a placebo Which is folic acid tablet with 150 cc of water (control group), respectively. Patients then enter the operating room and begin to surgery according to the previous surgical speculation. It should be noted that all patients will be monitored for hemodynamic and respiratory status immediately after receiving oral tramadol in a dose of 50 mg or placebo.

If tramadol is effective before surgery, the incidence of chills will be reduced initially before surgery.

In this study, a simple random method with individual units will be used. The patients are divided into two groups of 100 intervention and control using a table of random numbers generated by SPSS. The table of numbers produced will be available only to the statistician, and the researcher, clinical caregiver, and patient will not be aware of the contents of the medication package. If the patient enters the intervention group, they will receive a packet of medicine and if he enters the control group, they will receive a placebo. Medication Envelope and Tablet The drug or placebo is exactly the same in shape, size, envelope size, and pill size, and only the random numbers on the envelope are written on them. Neither the physician nor the patient knows which patient is receiving medication or placebo based on random numbers on each envelope. Only a statistician can access the random number table to find out which patient has received medication or placebo.

In this study, only the statistician knows the contents of the drug or placebo package, and researchers, patients, and clinical caregivers are blind to the data and prescription of the drug or placebo. After explaining to patients and obtaining informed consent, they will be explained that they may be in any of the groups receiving medication or placebo. The selection of patients to be in the group of receiving medication or placebo will be done by random software and random numbers, which is done by a statistician. The statistics expert has provided 100 envelopes containing unnamed and randomly numbered drugs, and 100 envelopes containing placebo and encoded with random numbers. The medicine and the pharmacopoeia and their packaging will be completely similar in shape, color and size. Anesthesiologists and health care providers in the operating room are blind to the contents of the envelope for medication or placebo, and only after entering the envelope code in the data collection form, they prescribe the contents to the patient, followed by cardiovascular and respiratory monitoring of all patients equally.

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