The Muscle Relaxation-study
This study has been completed.
Sponsor:
Herlev Hospital
Information provided by (Responsible Party):
Anne Kathrine Staehr, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01523886
First received: January 19, 2012
Last updated: November 19, 2012
Last verified: November 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 19, 2012 | ||||||||
| Last Updated Date | November 19, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Surgical space conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes ] [ Designated as safety issue: No ] The surgical space conditions (4-stage scale) assessed at the time during surgery, when they were poorest. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01523886 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Muscle Relaxation-study | ||||||||
| Official Title ICMJE | Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade | ||||||||
| Brief Summary | The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation. The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation. |
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| Detailed Description | The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Cholecystectomy, Laparoscopic | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 48 | ||||||||
| Completion Date | November 2012 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01523886 | ||||||||
| Other Study ID Numbers ICMJE | 2011-441 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Anne Kathrine Staehr, Herlev Hospital | ||||||||
| Study Sponsor ICMJE | Herlev Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Herlev Hospital | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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