Bispectral Index and Surgical Field

NCT03911544 | Completed DMC

• 1 other identifier: 20190006
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Consciousness Monitors; Laparoscopy

Keywords

Neuromuscular Agents; Bispectral Index

Outcome Measures

Primary Outcomes (1)

• Proportion of optimal surgical field score

  score 1 on a scale 1-4 (higher values represent a better outcome)

  up to 12 hours

Secondary Outcomes (5)

• Administration of neuromuscular block

  up to 12 hours

• Amount of anesthetics, narcotic analgesics and other adjuvants

  up to 12 hours

• BIS values (continues)

  up to 12 hours

• Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)

  1 day

• Amount of analgesics administered in PACU

  1 day

Study Arms (2)

TIVA anesthesia with BIS monitoring

ACTIVE COMPARATOR

The depth of anesthesia will be adjusted with the help of BIS monitoring.

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)

Interventions

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.

TIVA anesthesia with BIS monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged \> 18 years
• American Society of Anesthesiology (ASA) physical status 1 or 2
• Legally competent

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (9)

• 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.

  PMID: 24937564 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.

  PMID: 9357886 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.

  PMID: 12657845 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

  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.

  PMID: 26864853 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.

  PMID: 24809482 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.

  PMID: 24240315 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.

  PMID: 25789421 RESULT

• 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.

  PMID: 40026610 DERIVED

Related Links

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

Study Officials

• Elena Crescioli, M.D.

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 11, 2019
• Study Start: April 1, 2019
• Primary Completion: March 8, 2021
• Study Completion: March 11, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)