Intraoperative AwarenessNCT04252911
Standard Vs Supralabial Bispectral Index Scores
An observational study of Intraoperative Awareness, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
With the rise in number of surgeries, the medicolegal issues are on rise especially if patient had intraoperative awareness, which can also be detrimental to psychosocial behaviour of patient. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Awareness
- What is being tested?
- Bispectral index score
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2020to May 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of all genders of all age and BMI
Who may be able to join
- Age group: 18-65 yrs
- ASA status: 1-3
- Use of endotracheal tube for securing the airway
Who cannot join
- Facial deformity : scars, cleft lip, mole etc
- Presence of beard and moustache
- Use of supraglottic device
- Patient under regional anaesthesia
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Dr. Nitesh Goel, MBBS,DA,DNB, 9717773292, drniteshgoel@gmail.com
About this study
Official title: Comparative Study Between Standard Vs Supralabial Bispectral Index Scores
With the rise in number of surgeries, the medicolegal issues are on rise especially if patient had intraoperative awareness, which can also be detrimental to psychosocial behaviour of patient. Investigators plan to compare the BIS values, 'which is an indicator of awareness', from supralabial to standard forehead placement sites. If the results are corroborative then the supralabial site can be used for BIS monitoring in neurosurgical cases where it is not possible to to apply the forehead BIS strips.
Read the detailed description
Consequences of intraoperative awareness could be hemodynamic disturbances, long-lasting psychological problem and medicolegal issues. Bispectral index (BIS) is the most widely used noninvasive method to estimate level of consciousness. Complex electroencephalography (EEG) parameter that converts raw EEG data from the frontal cortex into a single number between 100 (fully awake) and 0 (isoelectric EEG).
The BIS sensor is a single adhesive strip placed across the forehead. This position can be problematic in certain surgical procedures involving a neurosurgery, surgery involving fronto-temporal area of the face. Thus the need for alternative sites for BIS sensor placement is often felt. Several alternative sensor positions have been reported in literature like Occipital, Retroauricular, Mandibular. Each of these are found to have limitations. Investigators planned a study to compare the BIS values at two sites i.e. forehead(standard) versus supralabial placement of sensors so that BIS can be applied in neurosurgical cases if the two values relates statistically.
Sample size: Total of 50 patients will be recruited for the study. Every patient will act as control and test group as both standard forehead sensors and (test) supralabial sensors will be applied in same patient.
Method:
2 BIS sensors will be applied on each patient soon after the induction.
- Sensor 1: Frontal sensors will be applied with circle 1 at the center of the forehead; circle 2, 2.8 cm lateral to circle 1; and circle 3 on either temporal area between the corner of the eye and the hairline.
- Sensor 2: Supralabial sensors will be applied with circle 1 at the center of the upper lip at phrenulum, circle 4 adjacent to the lateral side of lip, and circle 3 at the ipsilateral temporal area.
Anaesthetic technique:
All patients will be given anti-aspiration prophylaxis with tab pantoperazole 20mg and tab. Granicetrone 2mg orally 2hrs before surgery with sips of water. After informed consent and recruitment as per inclusion-exclusion criteria, all patients will be premedicated with inj. midazolam mg. i.v. followed by intravenous induction with inj. propofol (1-2.5mg/Kg) along with Inj. Atracurium for muscle relaxation.
Intubation will be done after adequate muscle relaxation achieved in both groups. Intraoperatively muscle relaxation will be monitored by nerve stimulator. Aim will be to maintain BIS value of 40-60. Closed circuit anaesthesia along with inhalational gas flow rate of 1 litre/min will be maintained. Patient will be ventilated with oxygen and sevoflurane mixture along with propofol infusion @ 25-100 mcg/kg/min Patient will be reversed after monitoring TOF ratio once the surgery is over.
Monitoring: following 3 parameters
- BIS score
- Signal quality index (SQI)
- Electromyography (EMG) score
Data will be recorded at
- Before first surgical incision
- After the first surgical incision
- Every 15 minutes thereafter during the intraoperative period (maintenance)
- Pre extubation
- Post extubation (emergence).
Proposed Statistical Analysis:
The statistical analysis will be carried out using Statistical Package for Social Sciences (SPSS Inc.,IBM, version 24.0 for Windows).
Bland- Altman plot will be used to assess agreement between the values obtained from standard placement site and supralabial sensors
- Conditions
- Intraoperative Awareness
- Being tested
- Bispectral index score
- Keywords
- BIS, Intraoperative awareness
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index scoreOther
Also called medtronic Bis Monitoring device
Bis value from two sites gives similar results
| Study group | Role | What they receive |
|---|---|---|
| Anaesthetised patients | 50 patients undergoing robotic surgeries under general anesthesia Receives: Other: Bispectral index score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative BIS values
the values from both sites will be monitored
Measured: from induction of anaesthesia till surgery is over upto 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Jan 2020
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative AwarenessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252911
- Sponsor's protocol ID
- RajivGCIRC3
- Status last verified
- Feb 2020
- First submitted
- 12 Nov 2019
- Last updated
- 18 Feb 2020
- 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 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Standard Vs Supralabial Bispectral Index Scores
- ClinicalTrials.gov ID
- NCT04252911
- Acronym / sponsor ID
- RajivGCIRC3
- Conditions
- Intraoperative Awareness
- Keywords
- BIS, Intraoperative awareness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
With the rise in number of surgeries, the medicolegal issues are on rise especially if patient had intraoperative awareness, which can also be detrimental to psychosocial behaviour of patient. Investigators plan to compare the BIS values, 'which is an indicator of awareness', from supralabial to standard forehead placement sites. If the results are corroborative then the supralabial site can be used for BIS monitoring in neurosurgical cases where it is not possible to to apply the forehead BIS strips.
Detailed description
Consequences of intraoperative awareness could be hemodynamic disturbances, long-lasting psychological problem and medicolegal issues. Bispectral index (BIS) is the most widely used noninvasive method to estimate level of consciousness. Complex electroencephalography (EEG) parameter that converts raw EEG data from the frontal cortex into a single number between 100 (fully awake) and 0 (isoelectric EEG).
The BIS sensor is a single adhesive strip placed across the forehead. This position can be problematic in certain surgical procedures involving a neurosurgery, surgery involving fronto-temporal area of the face. Thus the need for alternative sites for BIS sensor placement is often felt. Several alternative sensor positions have been reported in literature like Occipital, Retroauricular, Mandibular. Each of these are found to have limitations. Investigators planned a study to compare the BIS values at two sites i.e. forehead(standard) versus supralabial placement of sensors so that BIS can be applied in neurosurgical cases if the two values relates statistically.
Sample size: Total of 50 patients will be recruited for the study. Every patient will act as control and test group as both standard forehead sensors and (test) supralabial sensors will be applied in same patient.
Method:
2 BIS sensors will be applied on each patient soon after the induction.
- Sensor 1: Frontal sensors will be applied with circle 1 at the center of the forehead; circle 2, 2.8 cm lateral to circle 1; and circle 3 on either temporal area between the corner of the eye and the hairline.
- Sensor 2: Supralabial sensors will be applied with circle 1 at the center of the upper lip at phrenulum, circle 4 adjacent to the lateral side of lip, and circle 3 at the ipsilateral temporal area.
Anaesthetic technique:
All patients will be given anti-aspiration prophylaxis with tab pantoperazole 20mg and tab. Granicetrone 2mg orally 2hrs before surgery with sips of water. After informed consent and recruitment as per inclusion-exclusion criteria, all patients will be premedicated with inj. midazolam mg. i.v. followed by intravenous induction with inj. propofol (1-2.5mg/Kg) along with Inj. Atracurium for muscle relaxation.
Intubation will be done after adequate muscle relaxation achieved in both groups. Intraoperatively muscle relaxation will be monitored by nerve stimulator. Aim will be to maintain BIS value of 40-60. Closed circuit anaesthesia along with inhalational gas flow rate of 1 litre/min will be maintained. Patient will be ventilated with oxygen and sevoflurane mixture along with propofol infusion @ 25-100 mcg/kg/min Patient will be reversed after monitoring TOF ratio once the surgery is over.
Monitoring: following 3 parameters
- BIS score
- Signal quality index (SQI)
- Electromyography (EMG) score
Data will be recorded at
- Before first surgical incision
- After the first surgical incision
- Every 15 minutes thereafter during the intraoperative period (maintenance)
- Pre extubation
- Post extubation (emergence).
Proposed Statistical Analysis:
The statistical analysis will be carried out using Statistical Package for Social Sciences (SPSS Inc.,IBM, version 24.0 for Windows).
Bland- Altman plot will be used to assess agreement between the values obtained from standard placement site and supralabial sensors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaesthetised patients | – | Other: Bispectral index score50 patients undergoing robotic surgeries under general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all genders of all age and BMI
Key inclusion criteria (3 listed)
- Age group: 18-65 yrs
- ASA status: 1-3
- Use of endotracheal tube for securing the airway
Key exclusion criteria (4 listed)
- Facial deformity : scars, cleft lip, mole etc
- Presence of beard and moustache
- Use of supraglottic device
- Patient under regional anaesthesia
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 |
|---|---|---|
| Bispectral index scoreAlso: medtronic Bis Monitoring deviceBis value from two sites gives similar results | Other | Anaesthetised patients |
Primary outcome
Intraoperative BIS values
Time frame: from induction of anaesthesia till surgery is over upto 5 hours
the values from both sites will be monitored
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Awareness, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 4 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 18 Feb 2020. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Nitesh Goel, MBBS,DA,DNB (9717773292, drniteshgoel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative BIS values (time frame: from induction of anaesthesia till surgery is over upto 5 hours). 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 18 Feb 2020.