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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06177847
Other study ID # IndonesiaU432
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 15, 2023
Est. completion date February 28, 2024

Study information

Verified date December 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date February 28, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - Patients aged 30-60 years with an ASA tolerance of 1-2 who will undergo general anesthesia techniques - Operation duration > 3 hours - The patient agrees to take part in the study. Exclusion Criteria: - Continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents - Massive bleeding that causes hemodynamic disturbances - Severe electrolyte disturbances - Severe liver or kidney function disorders - The patient was decided not to extubate in the operating room

Study Design


Intervention

Device:
BIS
In the group with BIS where the anesthesia protocol is opened, namely the use of anesthetic gas, the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Outcome

Type Measure Description Time frame Safety issue
Primary Deep Hypnotic State the state of depth of anesthesia where the Bispectral Index value is <40. is calculated from the beginning of induction to the end of the operation and accumulated at the end of the operation. During surgery and up to 24 hours after surgery
Primary Total use of anesthetic agents The amount of anesthetic gas used from the start of the operation to the end of the operation During surgery and up to 24 hours after surgery
Primary Number of Participants with Hypotension and Bradycardia Intraoperative Intraoperative hypotension was defined as systolic blood pressure <90 mm Hg for >5 minutes or a 35% decrease in MAP. Intraoperative bradycardia was defined as a heart rate <60 beats/min for >5 minutes During surgery and up to 24 hours after surgery
Primary Vasopressor use Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery. Before surgery, during surgery, up to 24 hours after surgery
Primary Incidence of delirium The method for measuring the incidence of delirium will be assessed by researchers using the CAM (Confusion Assessment Method) questionnaire which has been validated in Indonesian up to 24 hour after surgery
Primary Incidence of mortality The incidence of death after surgery in hospital or outside the hospital up to 28 days after surgery
Primary Lenght of stay The length of stay is measured from days after surgery until being discharged from the hospital. From the date of randomization until 28 days after surgery
Primary Duration of recovery The duration of recovery was measured from post-operative day 0 until the patient was able to return to the patient's baseline function up to 7 days post operative
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