Bispectral Index and Surgical Field

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911544
• Other study ID #: 20190006
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 11, 2021

Study information

• Verified date: July 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 11, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Monitors
• Laparoscopy

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	North Jutland Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

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. — View 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.000000000000009 — View 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

Madsen MV, Gätke 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/a — View Citation

Madsen MV, Staehr-Rye AK, Claudius C, Gätke 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. Review. — View 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. — View Citation

Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;(6):CD003843. doi: 10.1002/14651858.CD003843.pub3. Review. Update in: Cochrane D — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of optimal surgical field score	score 1 on a scale 1-4 (higher values represent a better outcome)	up to 12 hours
Secondary	Administration of neuromuscular block	Total amount of neuromuscolar block given during anesthesia, expressed in milligrams	up to 12 hours
Secondary	Amount of anesthetics, narcotic analgesics and other adjuvants	Registration is in milligrams	up to 12 hours
Secondary	BIS values (continues)	continues values	up to 12 hours
Secondary	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
Secondary	Amount of analgesics administered in PACU	Registration is in milligrams	1 day

External Links

•   D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.