Comparison of Remifentanil use in spinal surgery with and without ANI(analgesia nociception Index) monitoring guidance

Comparison of Remifentanil use in spinal surgery under general anesthesia in two groups under ANI monitoring and without ANI monitoring

Block and single-blind randomized clinical trial in phase 3 on 60 patients undergoing general anesthesia for spinal surgery, in two parallel control and intervention groups, with and without ANI monitoring.

In this study, a single-blind randomized clinical trial for a researcher, by not stating the size of randomization blocks, patients undergoing general anesthesia for spinal surgery at Sina Hospital in Tehran were randomly divided into two groups with and without ANI monitoring. During surgery, depending on the BIS, between 40 and 60 infusions of propofol are administered in both groups and according to ANI values, between 50 and 70 infusions of remifentanil are prescribed in the group under ANI guidance.

Inclusion criteria: Patients between 18 and 70 years old, patients candidates for spinal surgery, ASA grade I-II and consent to study. Exclusion criteria: Patients with arrhythmia, patients taking beta-blockers, patients with neuromuscular diseases, diabetics and pregnant women, patients for whom pre- or postoperative ANI monitoring should be discontinued, patients who require Transfer to ICU without postoperative awakening, patients who had received medication before the intervention, lack of patient cooperation, drug addiction.

Control group: Candidate patients for spinal surgery under general anesthesia without ANI monitoring; Intervention group: Candidate patients for spinal surgery under general anesthesia under the guidance of ANI monitoring

The amount of remifentanil used during surgery; the amount of pain in recovery; The incidence of complications due to the administration of Remifentanyl.

The eligible patients were randomly assigned to the treatment and control groups using balanced block randomization with a block size of four. For this purpose, the treatment and control groups were randomly assigned to letters A and B. Thus, for each block of four patients, two sequence different assignments were made for each treatment. Six sheets of paper were used. In the papers were written all the possible states, i.e. Paper No. 1 for AABB, Paper No. 2 for ABAB, Paper No. 3 for ABBA, Paper No. 4 for BBAA, Paper No. 5 for BABA, and Paper No. 6 or BAAB. Then the number were selected randomly via table of random numbers. According to number of selected papers, the patients respectively were in the treatment or control groups.