Skip to main content
OpenTrials
Completed

NCT Number: NCT03911544

Bispectral Index and Surgical Field

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Consciousness Monitors Laparoscopy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS monitor

Device

Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Administration of neuromuscular block

    Time frame: up to 12 hours

    Total amount of neuromuscolar block given during anesthesia, expressed in milligrams

  2. Amount of anesthetics, narcotic analgesics and other adjuvants

    Time frame: up to 12 hours

    Registration is in milligrams

  3. BIS values (continues)

    Time frame: up to 12 hours

    continues values

  4. 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

  5. Amount of analgesics administered in PACU

    Time frame: 1 day

    Registration is in milligrams

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2019
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.