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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Dr. Nitesh Goel, MBBS,DA,DNB contact

9717773292

drniteshgoel@gmail.com

India1 site, 1 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

    Recruiting

Other trials in India

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

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 groups in NCT04252911
Study groupRoleWhat they receive
Anaesthetised patients50 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.

  1. 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.

  1. First posted5 Feb 2020
  2. Study start20 Jan 2020
  3. Primary completionApr 2020 (estimated)
  4. Study completionMay 2020 (estimated)

Resources

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)
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

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.

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