E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
The aim of the study is to investigate if muscle relaxation in the abomen improves operating conditions during operation in patients scheduled for non acute open upper abdominal surgery. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023697 |
E.1.2 | Term | Laparotomy & drainage |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051777 |
E.1.2 | Term | Staging laparotomy |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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)
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |