NCT02140593

Brief Summary

The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade. The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

May 13, 2014

Results QC Date

January 10, 2017

Last Update Submit

March 9, 2017

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Surgical Rating Score

    The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

    After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes

Secondary Outcomes (1)

  • The Surgical Rating Score During Fascial Closure

    Immediatly after fascial closure

Study Arms (2)

Standard neuromuscular blockade

PLACEBO COMPARATOR

Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).

Drug: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).

Deep neuromuscular blockade

ACTIVE COMPARATOR

Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Drug: Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Interventions

Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).DRUG
Standard neuromuscular blockade
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.DRUG
Deep neuromuscular blockade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years old
  • Elective open upper abdominal surgery
  • Can read and understand Danish
  • Informed consent

You may not qualify if:

  • Known allergy to rocuronium or sugammadex
  • Severe renal disease, defined by S-creatinine\> 0.200 mmol/L, GFR \< 30ml/min or hemodialysis
  • Neuromuscular disease that may interfere with neuromuscular data
  • Abdominal mesh with size larger than 5\*5 cm
  • Lactating or pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital Nørrebrogade

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • Madsen MV, Scheppan S, Mork E, Kissmeyer P, Rosenberg J, Gatke MR. Influence of deep neuromuscular block on the surgeons assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.

    PMID: 28969327DERIVED

  • Madsen MV, Scheppan S, Kissmeyer P, Mork E, Rosenberg J, Gatke MR. Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study. Dan Med J. 2015 Oct;62(10):A5139.

    PMID: 26441396DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Results Point of Contact

Title
Dr. Matias Vested Madsen
Organization
Herlev and Gentofte Hospital University of Copenhagen
matias.vested.madsen@regionh.dk
+4538683868

Study Officials

  • Matias V Madsen, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research assistant

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 16, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

April 20, 2017

Results First Posted

April 20, 2017

Record last verified: 2017-03

Locations

DK(1)