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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA anesthesia with BIS monitoring | Active Comparator | The 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of optimal surgical field score | score 1 on a scale 1-4 (higher values represent a better outcome) | up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Administration of neuromuscular block | Total amount of neuromuscolar block given during anesthesia, expressed in milligrams | up to 12 hours |
| Amount of anesthetics, narcotic analgesics and other adjuvants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Crescioli, M.D. | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | North Denmark | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24937564 | Result | 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. | |
| 9357886 | Result | Song 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. |
| Label | URL |
|---|---|
| D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. | View source |
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Registration is in milligrams
| up to 12 hours |
| BIS values (continues) | continues values | 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 | 1 day |
| Amount of analgesics administered in PACU | Registration is in milligrams | 1 day |
| 12657845 | Result | Ahmad 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. |
| Result | Kamal 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 |
| 26864853 | Result | 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. |
| 24809482 | Result | Dubois 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. |
| 24240315 | Result | Martini 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. |
| 25789421 | Result | Madsen 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. |
| 40026610 | Derived | Crescioli 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. |