E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical conditions during laparoscopic cholecystectomy |
Kirurgiske oversigtsforhold under laparoskopisk kolecystectomy |
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E.1.1.1 | Medical condition in easily understood language |
Surgical conditions during laparoscopic removal of the gallbladder |
Kirurgiske forhold ved kikkertkirurgisk fjernelse af galdeblæren |
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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 | PT |
E.1.2 | Classification code | 10008611 |
E.1.2 | Term | Cholecystectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients older than 18 years, who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg |
Formålet med denne undersøgelse er at sammenligne de kirurgiske oversigtsforhold ved to grader af neuromuskulær blokade hos patienter over 18 år, der får foretaget laparoskopisk kolecystektomi ved pneumoperitoneum 8 mmHg. |
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E.2.2 | Secondary objectives of the trial |
To compare the pain level after surgery with two degrees of neuromscular blockade |
At sammenligne niveauet af postoperative smerter efter operation ved to forskellige grader af neuromskulær blokade |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand Danish
Women must be post-menopaursal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives |
Patienter > 18 år
Elektiv laparoskopisk kolecystektomi (standard 4-hul)
Kan læse og forstå dansk
Kvinder skal opfylde 1 af de 3 følgende kriterier:
1) Postmenopausal defineret som udebleven menstruation i mindst 12 mdr. før inklusion i studiet
2) Kirurgisk steriliseret defineret som bilateral tubektomi eller hysterektomi og bilateral ovarektomi
3) Fertile kvinder skal benytte sikker antikonception defineret som spiral eller hormonel antikonception
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E.4 | Principal exclusion criteria |
Known allergy to medications that are included in the project
Presence of severe renal disease
Presence of neuromuscular disease
Presence of reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnant-test |
Kendt allergi for lægemidler, som indgår i projektet
Tilstedeværelse af kendt svær nyresygdom
Tilstedeværelse af kendt neuromuskulær sygdom, der kan interferere med neuromuskulære data
Tilstedeværelse af kendt nedsat leverfunktion
Ammende eller gravide
Indikation for akut anæstesiindledning
For fertile kvinder: Manglende negativ urin graviditetstest |
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E.5 End points |
E.5.1 | Primary end point(s) |
The surgical conditions assessed at the time during surgery, when they were poorest (4-stage scale) |
De kirurgiske oversigtsforhold vurderet på det tidspunkt under kirurgi, hvor de var dårligst (4-trins skala) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of surger |
Ved afslutning af kirurgi |
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E.5.2 | Secondary end point(s) |
1) The surgical conditions as described above (VAS 0-100)
2) The average surgical conditions (4-stage scale and VAS 0-100)
3) The surgical conditions during dissection of the gallbladder (4-stage scale and VAS 0-100)
4) Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery
5) Pain (shoulder, incision, deep abdominal and general) at arrival to the postanaesthesia department, 2 hours and 1 day after surgery
6) Number of days before re-establishing normal functional level
7) Number of procedures which can be done with a pneumoperitoneum at 8 mmHg
8) Duration of surgery
9) Duration of anaesthesia
10) Consumption of analgesics during the first 24 hours
11) Nausea and vomiting during the first 24 hours
12) Use of anti-emetics during the first 24 hours
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1)De kirurgiske oversigtsforhold som beskrevet ovenfor (VAS 0-100)
2)De gennemsnitlige kirurgiske oversigtsforhold (4-trins skala og VAS 0-100)
3)De kirurgiske oversigtsforhold ved dissektion af galdeblæren (4-trins skala og VAS 0-100)
4)Smerter (skulder-, sår-, dyb abdominal og overordnet smerte) vurderet som arealet under kurven fra præoperativt til 1 uge efter operation
5)Smerter (skulder-, sår-, dyb abdominal og overordnet smerte) ved ankomst til opvågningsafsnit, 2 timer postoperativt og 1 postoperative dag
6)Antal dage før genoptagelse af normalt funktionsniveau
7)Andel af laparoskopier, som gennemføres ved et pneumoperitoneum på 8 mmHg
8)Varighed af kirurgi (min)
9)Varighed af anæstesi (min)
10)Forbrug af oxycodon indtil 24 timer postoperativt
11)Forekomst af kvalme og opkastning indtil 24 timer postoperativt
12)Forbrug af antiemetika indtil 24 timer postoperativt
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) At the end of surgery
2) At the end of surgery
3) At dissection of the gallbladder
4) 7 days after surgery
5) At arrival to the postanaesthesia department, 2 hours after surgery and 1 day after surgery
6) 14 days after surgery
7) At the end of surgery
8) At the end of surgery
9) At the end of anaesthesia
10) 24 hours after surgery
11) 24 hours after surgery
12) 24 hours after surgery |
1) Ved afslutning af kirurgi
2) Ved afslutning af kirurgi
3) Ved dissektion af galdeblæren
4) 7 dage efter kirurgi
5) Ved ankomst til opvågningsafsnit, 2 timer postoperativt og 1 dag efter kirurgi
6) 14 dage efter kirurgi
7) Ved afslutning af kirurgi
8) Ved afslutning af kirurgi
9) Ved afslutning af anæstesi
10) 24 timer efter kirurgi
11) 24 timer efter kirurgi
12) 24 timer efter kirurgi |
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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 | 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 | 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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Inclusion of patients will be stopped when the desired number of patients is achieved. The trial will be counted as concluded, when the last patients has submitted the final pain scorings and the CRF is full-filled. This will be approximately 3 weeks after inclusion of the final patient. |
Inklusion af patienter stoppes, når det ønskede antal patienter er opnået. Forsøget regnes for afsluttet, når den sidste patient har haft den postoperative samtale, og CRF´en til denne patient er udfyldt. Dette vil ca. være 3 uger efter inklusion af denne sidste patient.
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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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |