Consciousness MonitorsNCT03911544
Bispectral Index and Surgical Field
A study testing BIS monitor in people with Consciousness Monitors and Laparoscopy, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Consciousness Monitors, Laparoscopy
- What is being tested?
- BIS monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 11 Mar 2021
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged > 18 years
- American Society of Anesthesiology (ASA) physical status 1 or 2
- Legally competent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Consciousness Monitors, Laparoscopy
- Being tested
- BIS monitor
- Keywords
- Neuromuscular Agents, Bispectral Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS monitorDevice
Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| TIVA anesthesia with BIS monitoring | Active comparator | The depth of anesthesia will be adjusted with the help of BIS monitoring. Receives: Device: BIS monitor |
| TIVA anesthesia without BIS monitoring | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of optimal surgical field score
score 1 on a scale 1-4 (higher values represent a better outcome)
Measured: up to 12 hours
Secondary outcomes (5)
Administration of neuromuscular block
Total amount of neuromuscolar block given during anesthesia, expressed in milligrams
Measured: up to 12 hours
Amount of anesthetics, narcotic analgesics and other adjuvants
Registration is in milligrams
Measured: up to 12 hours
BIS values (continues)
continues values
Measured: up to 12 hours
Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)
Registration of the drugs in in milligrams
Measured: 1 day
Amount of analgesics administered in PACU
Registration is in milligrams
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Apr 2019
- Primary completion8 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Consciousness MonitorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Crescioli, Aalborg University Hospital
- Investigators
- Elena Crescioli, M.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911544
- Sponsor's protocol ID
- 20190006
- Status last verified
- Jul 2021
- First submitted
- 6 Apr 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
PubMed 24937564Song D, Joshi GP, White PF. Titration of volatile anesthetics using bispectral index facilitates recovery after ambulatory anesthesia. Anesthesiology. 1997 Oct;87(4):842-8. doi: 10.1097/00000542-199710000-00018.
PubMed 9357886Ahmad S, Yilmaz M, Marcus RJ, Glisson S, Kinsella A. Impact of bispectral index monitoring on fast tracking of gynecologic patients undergoing laparoscopic surgery. Anesthesiology. 2003 Apr;98(4):849-52. doi: 10.1097/00000542-200304000-00010.
PubMed 12657845Kamal NM, Omar SH, Radwan KG,Youssef A. Bispectral Index Monitoring Tailors Clinical Anesthetic Delivery and Reduces Anesthetic Drug Consumption. Journal of Medical Sciences, 9: 10-16, 2009
Madsen MV, Staehr-Rye AK, Claudius C, Gatke MR. Is deep neuromuscular blockade beneficial in laparoscopic surgery? Yes, probably. Acta Anaesthesiol Scand. 2016 Jul;60(6):710-6. doi: 10.1111/aas.12698. Epub 2016 Feb 10.
PubMed 26864853Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
PubMed 24809482Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PubMed 24240315Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.
PubMed 25789421Crescioli E, Thyrrestrup PS, Almas T. Bispectral Index and Surgical Space Conditions in Day Surgery Benign Gynecological Laparoscopies: A Double-Blinded Randomized Clinical Trial. Anesthesiol Res Pract. 2025 Feb 23;2025:4558323. doi: 10.1155/anrp/4558323. eCollection 2025.
PubMed 40026610
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies
- ClinicalTrials.gov ID
- NCT03911544
- Acronym / sponsor ID
- 20190006
- Conditions
- Consciousness Monitors, Laparoscopy
- Keywords
- Neuromuscular Agents, Bispectral Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 11 Apr 2019 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA anesthesia with BIS monitoring | Active comparator | Device: BIS monitorThe depth of anesthesia will be adjusted with the help of BIS monitoring. |
| TIVA anesthesia without BIS monitoring | No intervention | –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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged > 18 years
- American Society of Anesthesiology (ASA) physical status 1 or 2
- Legally competent
Key exclusion criteria (6 listed)
- Age < 18 years
- ASA physical status ≥3
- Renal and/or lever disease
- Relevant allergies towards anesthetics
- Cancer surgery
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 |
|---|---|---|
| BIS monitorParticipants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia. | Device | TIVA anesthesia with BIS monitoring |
Primary outcome
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)
5 secondary outcomes
Administration of neuromuscular block
Time frame: up to 12 hours
Amount of anesthetics, narcotic analgesics and other adjuvants
Time frame: up to 12 hours
BIS values (continues)
Time frame: up to 12 hours
Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)
Time frame: 1 day
Amount of analgesics administered in PACU
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Results publication: PubMed 24937564Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
- Results publication: PubMed 9357886Song D, Joshi GP, White PF. Titration of volatile anesthetics using bispectral index facilitates recovery after ambulatory anesthesia. Anesthesiology. 1997 Oct;87(4):842-8. doi: 10.1097/00000542-199710000-00018.
- Results publication: PubMed 12657845Ahmad S, Yilmaz M, Marcus RJ, Glisson S, Kinsella A. Impact of bispectral index monitoring on fast tracking of gynecologic patients undergoing laparoscopic surgery. Anesthesiology. 2003 Apr;98(4):849-52. doi: 10.1097/00000542-200304000-00010.
- Results publicationKamal NM, Omar SH, Radwan KG,Youssef A. Bispectral Index Monitoring Tailors Clinical Anesthetic Delivery and Reduces Anesthetic Drug Consumption. Journal of Medical Sciences, 9: 10-16, 2009
- Results publication: PubMed 26864853Madsen MV, Staehr-Rye AK, Claudius C, Gatke MR. Is deep neuromuscular blockade beneficial in laparoscopic surgery? Yes, probably. Acta Anaesthesiol Scand. 2016 Jul;60(6):710-6. doi: 10.1111/aas.12698. Epub 2016 Feb 10.
- Results publication: PubMed 24809482Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
- Results publication: PubMed 24240315Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
- Results publication: PubMed 25789421Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.
- Derived from this study: PubMed 40026610Crescioli E, Thyrrestrup PS, Almas T. Bispectral Index and Surgical Space Conditions in Day Surgery Benign Gynecological Laparoscopies: A Double-Blinded Randomized Clinical Trial. Anesthesiol Res Pract. 2025 Feb 23;2025:4558323. doi: 10.1155/anrp/4558323. eCollection 2025.
- D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elena Crescioli, M.D. principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS monitor in people with Consciousness Monitors and Laparoscopy, run by Aalborg University Hospital at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 20 Jul 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of optimal surgical field score (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911544, which also lists 9 linked publications.
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 20 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.