The effect of melatonin on drug consumption and hemodynamic responses after laryngoscopy in addiction to opium patients, candidates for elective lumbar spine surgery

Investigating the effect of melatonin on the amount of narcotic consumption and hemodynamic responses after laryngoscopy in opium-addicted patients in elective lumbar spine surgery.

A clinical trial with a control and intervention group, double-blind, on 64 patients, randomization with a sealed envelope.

Patients with drug addiction who take daily and continuous at least 1 mg or its equivalent of mu receptor agonist substances for at least 6 months and who experience withdrawal symptoms if not taken, were randomly assigned to the melatonin or placebo group. 32 people each) will be placed. The melatonin group will receive two melatonin tablets (3 mg each) and the placebo group will receive two placebo tablets 120 minutes before induction. Hemodynamic parameters will be recorded during induction and after intubation for 15 minutes. The total induction dose of propofol, the total intraoperative fentanyl intake and the adverse effects of melatonin will also be mentioned.The patient, the registrar and the analyzer of the results do not know about the division.

Inclusion criteria: opium addiction, patient satisfaction, ASA 1,2 Exclusion criteria: difficult airway, body mass index above 30 kg/m2, use of anti-anxiety, sedative, anti-psychotic and anti-epileptic drugs, patients with sleep disorder, hiatus hernia and gastroesophageal reflux, known allergy to melatonin and a known case of coronary artery disease

The melatonin group will receive two tablets (3 mg each) of melatonin and the placebo group will receive two placebo tablets 120 minutes before induction.

Blood pressure and heart rate before anesthesia up to 15 minutes after laryngoscopy, amount of narcotics and anesthetics drug

Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer Software R. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached.

Forms with numbers 1 and 2 inside the packed envelopes are used to group the patients, which are randomly given to the patients and the patients do not know about the groupings. It is opened and according to the intervention group, the drug or placebo that was prepared in advance is given to the patient. The clinical caregiver does not know about the grouping. The evaluator and recorder of the results and the person analyzing the data also do not know about the grouping.