Hypnotic; Withdrawal State With DeliriumNCT06177847
Efficacy of BIS Monitoring in Deep Hypnotic State
A study testing BIS in people with Hypnotic; Withdrawal State With Delirium and Neurological Disorder, run by Universitas Indonesia.
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 Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypnotic; Withdrawal State With Delirium, Neurological Disorder, Postoperative Delirium
- What is being tested?
- BIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery
Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients
Read the detailed 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
- Conditions
- Hypnotic; Withdrawal State With Delirium, Neurological Disorder, Postoperative Delirium, Postoperative Confusion, Anesthesia, Anesthesia Emergence Delirium
- Being tested
- BIS
- Keywords
- Deep Hypnotic State, Anesthesia, Postoperative complication, Neurosurgical disorder
- Medical subject headings
- Nervous System Diseases, Emergence Delirium, Mucopolysaccharidosis IV, Respiratory Aspiration, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISDevice
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
| Study group | Role | What they receive |
|---|---|---|
| BIS Guided | Experimental | 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 Receives: Device: BIS |
| BIS Blinded | No intervention | The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery and up to 24 hours after surgery
Total use of anesthetic agents
The amount of anesthetic gas used from the start of the operation to the end of the operation
Measured: During surgery and up to 24 hours after surgery
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
Measured: During surgery and up to 24 hours after surgery
Vasopressor use
Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery.
Measured: Before surgery, during surgery, up to 24 hours after surgery
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
Measured: up to 24 hour after surgery
Incidence of mortality
The incidence of death after surgery in hospital or outside the hospital
Measured: up to 28 days after surgery
Lenght of stay
The length of stay is measured from days after surgery until being discharged from the hospital.
Measured: From the date of randomization until 28 days after surgery
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
Measured: up to 7 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypnotic; Withdrawal State With DeliriumStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bintang Pramodana, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177847
- Sponsor's protocol ID
- IndonesiaU432
- Status last verified
- Dec 2023
- First submitted
- 21 Sep 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery
- ClinicalTrials.gov ID
- NCT06177847
- Acronym / sponsor ID
- IndonesiaU432
- Conditions
- Hypnotic; Withdrawal State With Delirium, Neurological Disorder, Postoperative Delirium, Postoperative Confusion, Anesthesia, Anesthesia Emergence Delirium
- Keywords
- Deep Hypnotic State, Anesthesia, Postoperative complication, Neurosurgical disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| BIS Guided | Experimental | Device: BISIn 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 |
| BIS Blinded | No intervention | –The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BISIn 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 | Device | BIS Guided |
Primary outcome
Deep Hypnotic State
Time frame: During surgery and up to 24 hours after surgery
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.
Total use of anesthetic agents
Time frame: During surgery and up to 24 hours after surgery
The amount of anesthetic gas used from the start of the operation to the end of the operation
Number of Participants with Hypotension and Bradycardia Intraoperative
Time frame: During surgery and up to 24 hours after surgery
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
Vasopressor use
Time frame: Before surgery, during surgery, up to 24 hours after surgery
Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery.
Incidence of delirium
Time frame: up to 24 hour after surgery
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
Incidence of mortality
Time frame: up to 28 days after surgery
The incidence of death after surgery in hospital or outside the hospital
Lenght of stay
Time frame: From the date of randomization until 28 days after surgery
The length of stay is measured from days after surgery until being discharged from the hospital.
Duration of recovery
Time frame: up to 7 days post operative
The duration of recovery was measured from post-operative day 0 until the patient was able to return to the patient's baseline function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BIS in people with Hypnotic; Withdrawal State With Delirium and Neurological Disorder, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep Hypnotic State (time frame: During surgery and up to 24 hours after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.