NCT04252911

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 12, 2019

Last Update Submit

February 16, 2020

Conditions

Intraoperative Awareness

Keywords

BISIntraoperative awareness

Outcome Measures

Primary Outcomes (1)

  • Intraoperative BIS values

    the values from both sites will be monitored

    from induction of anaesthesia till surgery is over upto 5 hours

Study Arms (1)

Anaesthetised patients

50 patients undergoing robotic surgeries under general anesthesia

Other: Bispectral index score

Interventions

Bispectral index scoreOTHER

Bis value from two sites gives similar results

Also known as: medtronic Bis Monitoring device
Anaesthetised patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of all genders of all age and BMI

You may qualify if:

  • Age group: 18-65 yrs
  • ASA status: 1-3
  • Use of endotracheal tube for securing the airway

You may not qualify if:

  • Facial deformity : scars, cleft lip, mole etc
  • Presence of beard and moustache
  • Use of supraglottic device
  • Patient under regional anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Nitesh Goel, MBBS,DA,DNB

CONTACT

9717773292drniteshgoel@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesia, Principle investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

February 5, 2020

Study Start

January 20, 2020

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

IN(1)