Surgical conditions during laparoscopic cholecystectomy MedDRA version: 14.1 Level: PT Classification code 10008611 Term: Cholecystectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Esmeron
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROCURONIUM BROMIDE
CAS Number: 119302-91-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Mona R Gätke
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To compare the pain level after surgery with two degrees of neuromscular blockade;Primary end point(s): The surgical conditions assessed at the time during surgery, when they were poorest (4-stage scale);Timepoint(s) of evaluation of this end point: At the end of surger | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anesthesia
Mona R Gätke
Outcome results
None listed