E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing elective in-patient laparoscopic cholecystectomy procedures under general anesthesia with neuromuscular relaxation and active reversal of neuromuscular blockade |
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E.1.1.1 | Medical condition in easily understood language |
Abdominal surgical procedure to remove the gallbladder. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018061 |
E.1.2 | Term | General anesthesia |
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 primary objective of the trial is to assess the benefit of deep neuromuscular blockade in surgical conditions when compared to standard neuromuscular blockade in patients undergoing elective in-patient laparoscopic cholecystectomy procedures. |
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E.2.2 | Secondary objectives of the trial |
The key secondary trial objective is to assess whether the use of low insufflation pressure improves the overall patient's pain score within 24 hours (average of all pain assessments at 1, 2, 4 and 24 h) as compared to standard insufflation pressure, based on a standard pain scale following a laparoscopic cholecystectomy. An additional secondary objective for this study is to evaluate the visual field during laparoscopy (as determined by the surgeon) after use of sustained deep neuromuscular blockade compared to standard neuromuscular blockade. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must be: Males/Females ≥ 18 yrs; ASA (American Society of Anesthesiologists) Class 1, 2 or 3; scheduled for laparoscopic cholecystectomy (standard 4-hole) procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil and is expected to undergo rocuronium-induced neuromuscular blockade for endotracheal intubation and require active reversal of neuromuscular blockade. |
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E.4 | Principal exclusion criteria |
Subjects with neuromuscular disorders that may affect neuromuscular blockade and/or assessments will be excluded from this study, in addition subjects who cannot meeting general standards for anesthesia trials (inability to intubate, renal/hepatic dysfunction, allergies to general anesthesia medications, malignant hyperthermia, interactions with toremifene/fusidic acid, pregnant patients, previous enrollment in trials or relation to staff) will also be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary Endpoint for the trial is the surgeon's overall satisfaction with the surgical conditions rated at the end of the surgery using a numerical scale with scores from 0 (=poor, needed intervention) to 10 (=excellent). The Primary Efficacy Endpoint is related to the Primary Trial Objective. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This evaluation will occur within 2 hours of completion of surgical procedure. |
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E.5.2 | Secondary end point(s) |
The Key Secondary Endpoint for the trial is the patient's overall reported pain as measured by a numerical scale with scores from 0 (no pain) to 10 (severe) within 24 hours (average of all pain assessments at 1, 2, 4 and 24 hours).
This trial will also explore the following secondary endpoints:
-Surgeon's satisfaction with the visibility of the surgical field rated at the end of the
-surgery using a numerical scale with scores from 0 (unacceptable visibility) to 10 (excellent)
-Surgeon's overall rating of the adequacy of muscle relaxation and insufflation pressure during surgery using a numerical scale with scores from 0 (=unacceptable muscle relaxation, required intervention) to 10 (=excellent)
-Number of patient's movements that interfered with the surgical conditions during laparoscopy (includes abdominal muscle contractions, diaphragm movement, breathing/coughing against the ventilator, hiccups, patient movements)
-Surgeon's assessment on the effect that these variables had on the overall surgical procedure (using numerical scale with scores of 0-10)
-Number of rescue actions performed during surgery in order to improve insufficient surgical conditions
-Daily assessments of patient reported overall pain and shoulder pain at rest and provoked (i.e. in connection with the transition from lying to sitting position) using a numerical scale with scores (0 to 10) starting on Day 2 up to and including the Follow-Up Visit (Day 8)
-Post-operative consumption of analgesic medications
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Key secondary endpoint will be evaluated over 24 hours post surgery. Additional secondary endpoints will be evaluated during surgery through Day 8, depending on the endpoint. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |