Renal SurgeriesNCT05451823
Post-auricular Versus Frontal Bispectral Index
A study testing Post auriclar-frontal in people with Renal Surgeries, run by Tanta University at 1 site in Egypt.
Trial summary
Electroencephalogram (EEG) derived monitors during practice of general anesthesia; allow the titration and maintenance of an adequate depth of anesthesia, advantages from reducing the recovery time after waking, as well as the risk of anesthetics adverse events . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Surgeries
- What is being tested?
- Post auriclar-frontal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 27 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged≥18 years
- ASA I-III
- patients scheduled for elective renal surgeries
Who cannot join
- Patients with disabling central nervous system
- cerebrovascular disease
- those currently taking psychiatric medication
- those with a history of neurosurgical intervention
- those with contraindications for the placement of electrodes over forehead and post-auricular area (e.g., having skin infections)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Post-auricular and Frontal Bispectral Index Values Obtained During Renal Surgeries
Electroencephalogram (EEG) derived monitors during practice of general anesthesia; allow the titration and maintenance of an adequate depth of anesthesia, advantages from reducing the recovery time after waking, as well as the risk of anesthetics adverse events .
There are various types of EEG-derived monitoring devices that are used to monitor the depth of anesthesia, and among the established devices is bispectral index (BIS) monitor. It is a quantitative electroencephalographic device that is widely used to assess the hypnotic component of anesthesia, and a level between 40 and 60 is recommended for an adequate level of the hypnotic state.
Read more
However, the use of BIS in certain surgeries is challenging because of the proximity of the forehead sensor to the surgical site. There are high possibilities of interruption of BIS recording due to contamination of the forehead sensor with blood or antiseptic cleaning solution. At the same time, the design and size of a BIS forehead sensor in the form of a long strip can also interfere with the site of surgical incision.
Several alternative BIS sensor placements have been studied for cases in which the frontal setup is not feasible. However, few studies studied the placement of the BIS sensor at the post-auricular area as an alternative method of monitoring the depth of anesthesia.
Read the detailed description
Twelve Patients age ≥18 years, ASA I-III patients scheduled for elective renal surgeries.
Monitoring of the depth of anesthesia will be performed using an Infinity BISx SmartPod® (Aspect Medical Systems, Newton, MA, USA) and an Infinity® Delta XL monitor (Dräger Medical, Lübeck, Germany). Two standard BISx Quatro® Sensors (Aspect Medical Systems) were placed at the forehead and post-auricular area.
Before the induction of anesthesia, 2 BIS sensors (BISTM Quatro Sensors, Aspect Medical Systems, Newton, MA, USA) will be applied to each patient, 1 across the forehead and 1 along the post auricular area and attached each sensor to each BIS monitor (BIS-VistaTM monitors, Aspect Medical Systems, Newton, MA, USA).
During induction, patients will be instructed to keep their faces relaxed (eyes closed, mouth closed, no facial expressions).
The skin on the forehead will be cleaned with an alcohol 70% swab, and 2 to 5 seconds of digital pressure applied over the sensor leads. The sensor is comprised of disposable wet gel electrodes. Electromyographic activity of the frontalis muscle is measured by lead 4, which is the ground electrode as well.
Frontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline.
Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline.
The titration of anesthetic depth will be maintained at BIS values between 40-60.
Sudden, high EMG scores were identified as artifacts and the associated BIS values were eliminated in data analysis.
Measurements:
From each BIS monitor, the investigators will collect 3 pieces of data at each of 6 times points: BIS score, signal quality index (SQI) score determining the strength of the signal, and electromyography (EMG) score: before the induction of anesthesia (awake), at loss of the eyelash reflex (LOC), after intubation (intubation), after the first surgical incision (incision), every 30 minutes during the intraoperative period (maintenance), and at spontaneous eye opening upon emergence from anesthesia (emergence).
- Conditions
- Renal Surgeries
- Being tested
- Post auriclar-frontal
- Keywords
- frontal bispectral index, post-auricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post auriclar-frontalDevice
Frontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline.
Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline.
| Study group | Role | What they receive |
|---|---|---|
| Post auriclar-frontal | Experimental | Frontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline.
Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline. Receives: Device: Post auriclar-frontal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-auricular and frontal BIS values
Post-auricular and frontal BIS values
Measured: 5 minutes before induction of aneasthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Jan 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal SurgeriesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Faheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451823
- Sponsor's protocol ID
- post-auricular bispectral
- Status last verified
- Sep 2023
- First submitted
- 26 Jun 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelrahman AMF, Elbadry AA, Omara AF. Comparison of post-auricular and frontal bispectral index values obtained during renal surgeries. BMC Anesthesiol. 2023 Dec 19;23(1):417. doi: 10.1186/s12871-023-02372-x.
PubMed 38114941
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post-auricular and Frontal Bispectral Index Values Obtained During Renal Surgeries
- ClinicalTrials.gov ID
- NCT05451823
- Acronym / sponsor ID
- post-auricular bispectral
- Conditions
- Renal Surgeries
- Keywords
- frontal bispectral index, post-auricular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 11 Jul 2022 (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.
Electroencephalogram (EEG) derived monitors during practice of general anesthesia; allow the titration and maintenance of an adequate depth of anesthesia, advantages from reducing the recovery time after waking, as well as the risk of anesthetics adverse events .
There are various types of EEG-derived monitoring devices that are used to monitor the depth of anesthesia, and among the established devices is bispectral index (BIS) monitor. It is a quantitative electroencephalographic device that is widely used to assess the hypnotic component of anesthesia, and a level between 40 and 60 is recommended for an adequate level of the hypnotic state.
However, the use of BIS in certain surgeries is challenging because of the proximity of the forehead sensor to the surgical site. There are high possibilities of interruption of BIS recording due to contamination of the forehead sensor with blood or antiseptic cleaning solution. At the same time, the design and size of a BIS forehead sensor in the form of a long strip can also interfere with the site of surgical incision.
Several alternative BIS sensor placements have been studied for cases in which the frontal setup is not feasible. However, few studies studied the placement of the BIS sensor at the post-auricular area as an alternative method of monitoring the depth of anesthesia.
Detailed description
Twelve Patients age ≥18 years, ASA I-III patients scheduled for elective renal surgeries.
Monitoring of the depth of anesthesia will be performed using an Infinity BISx SmartPod® (Aspect Medical Systems, Newton, MA, USA) and an Infinity® Delta XL monitor (Dräger Medical, Lübeck, Germany). Two standard BISx Quatro® Sensors (Aspect Medical Systems) were placed at the forehead and post-auricular area.
Before the induction of anesthesia, 2 BIS sensors (BISTM Quatro Sensors, Aspect Medical Systems, Newton, MA, USA) will be applied to each patient, 1 across the forehead and 1 along the post auricular area and attached each sensor to each BIS monitor (BIS-VistaTM monitors, Aspect Medical Systems, Newton, MA, USA).
During induction, patients will be instructed to keep their faces relaxed (eyes closed, mouth closed, no facial expressions).
The skin on the forehead will be cleaned with an alcohol 70% swab, and 2 to 5 seconds of digital pressure applied over the sensor leads. The sensor is comprised of disposable wet gel electrodes. Electromyographic activity of the frontalis muscle is measured by lead 4, which is the ground electrode as well.
Frontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline.
Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline.
The titration of anesthetic depth will be maintained at BIS values between 40-60.
Sudden, high EMG scores were identified as artifacts and the associated BIS values were eliminated in data analysis.
Measurements:
From each BIS monitor, the investigators will collect 3 pieces of data at each of 6 times points: BIS score, signal quality index (SQI) score determining the strength of the signal, and electromyography (EMG) score: before the induction of anesthesia (awake), at loss of the eyelash reflex (LOC), after intubation (intubation), after the first surgical incision (incision), every 30 minutes during the intraoperative period (maintenance), and at spontaneous eye opening upon emergence from anesthesia (emergence).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post auriclar-frontal | Experimental | Device: Post auriclar-frontalFrontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline. Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged≥18 years
- ASA I-III
- patients scheduled for elective renal surgeries
Key exclusion criteria (5 listed)
- Patients with disabling central nervous system
- cerebrovascular disease
- those currently taking psychiatric medication
- those with a history of neurosurgical intervention
- those with contraindications for the placement of electrodes over forehead and post-auricular area (e.g., having skin infections)
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 |
|---|---|---|
| Post auriclar-frontalFrontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline. Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline. | Device | Post auriclar-frontal |
Primary outcome
Post-auricular and frontal BIS values
Time frame: 5 minutes before induction of aneasthesia
Post-auricular and frontal BIS values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 38114941Abdelrahman AMF, Elbadry AA, Omara AF. Comparison of post-auricular and frontal bispectral index values obtained during renal surgeries. BMC Anesthesiol. 2023 Dec 19;23(1):417. doi: 10.1186/s12871-023-02372-x.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post auriclar-frontal in people with Renal Surgeries, run by Tanta University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-auricular and frontal BIS values (time frame: 5 minutes before induction of aneasthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451823, which also lists 1 linked publication.
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 11 Sep 2023.