Muscle relaxation during open abdominal surgery -can the surgiceon have better operating conditions? (The laparotomy study)

Muscle relaxation during open upper abdominal surgery -can the surgical conditions be optimized? (The laparotomy study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001155-22-DK

Enrollment

Unknown

Registered

2014-03-21

Start date

2014-05-22

Completion date

Unknown

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 17.0 Level: LLT Classification code 10023697 Term: Laparotomy & drainage System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10051777 Term: Staging laparotomy System Organ Class: 100000004865

Interventions

Trade Name: Esmeron Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ROCURONIUM Other descriptive name: Esmeron Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients > 18 years old Elective open upper abdominal surgery: Whipple, gastrectomy, gastric resection, liver resection and laparotomies due to bile obstruction i.e. hepaticojejunostomy (not cholecystectomy) Can read and understand Danish Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. Hypothesis: Intense NMB (PTC 0-1) compared to standard NMB improves average of surgical condition scores evaluated on a subjective rating scale. ;Secondary Objective: Secondary outcomes: -The surgical rating score during fascial closure -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) during fascial closure (instances where the surgeon asks for intervention) -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) to optimize surgical conditions (instances where the surgeon asks for intervention) -Frequencies of surgical rating scores of 1 or 2 in each patient -Number of patients with need for increasing the initial incision -Number of patients with sudden retractions during the procedure (bucking or coughing) -Operating time (total and during abdominal wall closure) -Wound dehiscence -Wound infection which requires surgical drainage -Incisional hernia (6 months follow up) ;Primary end point(s): The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure.;Timepoint(s) of evaluation of this end point: During the operation	—

Measure

Time frame

Main Objective: 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. Hypothesis: Intense NMB (PTC 0-1) compared to standard NMB improves average of surgical condition scores evaluated on a subjective rating scale. ;Secondary Objective: Secondary outcomes: -The surgical rating score during fascial closure -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) during fascial closure (instances where the surgeon asks for intervention) -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) to optimize surgical conditions (instances where the surgeon asks for intervention) -Frequencies of surgical rating scores of 1 or 2 in each patient -Number of patients with need for increasing the initial incision -Number of patients with sudden retractions during the procedure (bucking or coughing) -Operating time (total and during abdominal wall closure) -Wound dehiscence -Wound infection which requires surgical drainage -Incisional hernia (6 months follow up) ;Primary end point(s): The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure.;Timepoint(s) of evaluation of this end point: During the operation

—

Secondary

Measure	Time frame
Secondary end point(s): -The surgical rating score during fascial closure -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) during fascial closure (instances where the surgeon asks for intervention) -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) to optimize surgical conditions (instances where the surgeon asks for intervention) -Frequencies of surgical rating scores of 1 or 2 in each patient -Number of patients with need for increasing the initial incision -Number of patients with sudden retractions during the procedure (bucking or coughing) -Operating time (total and during abdominal wall closure) -Wound dehiscence -Wound infection which requires surgical drainage -Incisional hernia (6 months follow up) ;Timepoint(s) of evaluation of this end point: During the operation and during postoperative hospital stay and six months after operation	—

Measure

Time frame

Secondary end point(s): -The surgical rating score during fascial closure -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) during fascial closure (instances where the surgeon asks for intervention) -Number of patients with need for intervention (NMB/saline (placebo) or increased depth of anesthesia) to optimize surgical conditions (instances where the surgeon asks for intervention) -Frequencies of surgical rating scores of 1 or 2 in each patient -Number of patients with need for increasing the initial incision -Number of patients with sudden retractions during the procedure (bucking or coughing) -Operating time (total and during abdominal wall closure) -Wound dehiscence -Wound infection which requires surgical drainage -Incisional hernia (6 months follow up) ;Timepoint(s) of evaluation of this end point: During the operation and during postoperative hospital stay and six months after operation

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Countries

Denmark

Contacts

Public ContactDepartment of Anesthesiology

Mona Ring Gätke

mona.gatke@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026