Bispectral Index and Surgical Field

July 18, 2021 updated by: Elena Crescioli, Aalborg University Hospital

Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies

This study investigates whether BIS monitor assisted anesthesia improves surgical space conditions during gynecological benign laparoscopic procedures.

Half of participants will receive BIS monitor assisted anesthesia, while the other half will receive anesthesia without BIS monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General Anesthesia includes hypnosis/unconsciousness, amnesia, analgesia, muscle relaxation and autonomic and sensory blockade of responses to noxious stimulation.

Depth of anesthesia in standard practice is controlled by monitoring equipment such as blood pressure (BP), heart rate (HR), train of four ratio (TOF) and by clinical signs such as profuse sweating, tearing, cough and movements.

BIS can be used as additional tool to monitor and manage anesthesia. BIS is an empirically derived scale for measuring brain electrical activity. It computes an index between 0 and 100, whereas 0 corresponds to "no detectable brain electrical activity" (flatline EEG) and 100 to awake state. A patient is considered to be appropriately anesthetized when the BIS' value is between 40 and 60.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • North Jutland Region
      • Aalborg, North Jutland Region, Denmark, 9000
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged > 18 years
  • American Society of Anesthesiology (ASA) physical status 1 or 2
  • Legally competent

Exclusion Criteria:

  • Age < 18 years
  • ASA physical status ≥3
  • Renal and/or lever disease
  • Relevant allergies towards anesthetics
  • Cancer surgery
  • No informed consent or inability to give that

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TIVA anesthesia with BIS monitoring
The depth of anesthesia will be adjusted with the help of BIS monitoring.
Device: BIS monitor
Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.
No Intervention: TIVA anesthesia without BIS monitoring
The depth of anesthesia will adjusted as in standard practice (clinical signs of poor anesthesia such as increase in blood pressure and/or heart rate, tearing and profuse sweating)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of optimal surgical field score
Time Frame: up to 12 hours
score 1 on a scale 1-4 (higher values represent a better outcome)
up to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of neuromuscular block
Time Frame: up to 12 hours
Total amount of neuromuscolar block given during anesthesia, expressed in milligrams
up to 12 hours
Amount of anesthetics, narcotic analgesics and other adjuvants
Time Frame: up to 12 hours
Registration is in milligrams
up to 12 hours
BIS values (continues)
Time Frame: up to 12 hours
continues values
up to 12 hours
Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)
Time Frame: 1 day
Registration of the drugs in in milligrams
1 day
Amount of analgesics administered in PACU
Time Frame: 1 day
Registration is in milligrams
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Elena Crescioli, M.D., Aalborg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 11, 2021

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20190006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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