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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02140593
Other study ID # Lap2014NMB
Secondary ID 2014-001155-22
Status Completed
Phase Phase 4
First received May 13, 2014
Last updated October 31, 2016
Start date September 2014

Study information

Verified date October 2016
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients > 18 years old

- Elective open upper abdominal surgery

- Can read and understand Danish

- Informed consent

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

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.


Locations

Country Name City State
Denmark Aarhus University Hospital Nørrebrogade Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes No
Secondary The surgical rating score during fascial closure After last suture of fascial closure surgical conditions are rated on a 5 point scale Immediatly after fascial closure No
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