Clinical trial NCT03911544: Bispectral Index and Surgical Field
Official title: Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consciousness Monitors
Laparoscopy
Keywords: Neuromuscular Agents
Bispectral Index
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of optimal surgical field score
timeFrame: up to 12 hours
Secondary outcomes:
measure: Administration of neuromuscular block
timeFrame: up to 12 hours
measure: Amount of anesthetics, narcotic analgesics and other adjuvants
timeFrame: up to 12 hours
measure: BIS values (continues)
timeFrame: up to 12 hours
measure: Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)
timeFrame: 1 day
measure: Amount of analgesics administered in PACU
timeFrame: 1 day
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Jutland Region
Study officials:
affiliation: Aalborg University Hospital
name: Elena Crescioli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.