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Clinical Trial Summary

Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients


Clinical Trial Description

This study will be conducted with a two-group, double-blind, randomized clinical trial design in elective patients who will undergo neurosurgical procedures under general anesthesia. Patients scheduled for elective neurosurgery who meet the inclusion criteria will be randomized into one of the intervention groups, with or without BIS. Demographic data will be taken from medical records. In both groups, the BIS probe will be inserted before induction, but for the control group, the BIS monitor will be closed, while for the intervention group, anesthesia will be titrated according to the BIS value to maintain the BIS value in the range of 40-60. In the group with an open BIS, the anesthesia protocol is the use of anesthetic gas, and the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided, while the anesthesia protocol used in a closed BIS is carried out like general anesthesia without using BIS. The BIS value will be recorded minute by minute according to the extraction feature of the BIS machine after surgery. The total use of anesthetic agents, duration of surgery, and intraoperative hemodynamics will be recorded through anesthesia status. The patient will follow the progress until the patient is discharged from the hospital ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06177847
Study type Interventional
Source Indonesia University
Contact
Status Not yet recruiting
Phase N/A
Start date December 15, 2023
Completion date February 28, 2024

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