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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003787-51 | EudraCT Number |
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The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).
Primary hypothesis:
Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular blockade | Active Comparator | Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron |
|
| Moderate neuromuscular blockade | Placebo Comparator | Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain | Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100). | within 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation. Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation. Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-movements | Number of unintended and unwanted patient-movements registered by the surgeon | During surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Gätke, MD, ph.d. | Department of anesthesia, Herlev Hospital | Study Chair |
| Matias Vested Maden, MD | Department of anesthesia, Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet | Søborg | 2830 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28552090 | Derived | Madsen MV, Istre O, Springborg HH, Staehr-Rye AK, Rosenberg J, Lund J, Gatke MR. Deep neuromuscular blockade and low insufflation pressure during laparoscopic hysterectomy. Dan Med J. 2017 May;64(5):A5364. | |
| 26479510 | Derived | Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Blockade | Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron Rocuronium |
| FG001 | Moderate Neuromuscular Blockade | Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Neuromuscular Blockade | Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron Rocuronium |
| BG001 | Moderate Neuromuscular Blockade |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shoulder Pain | Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100). | Posted | Number | participants | within 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep Neuromuscular Blockade | Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron Rocuronium |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection after surgery | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matias Vested Madsen | Herlev Hospital, University of Copenhagen, Department of Anaesthesiology | +45 38683868 | matias.vested.madsen@regionh.dk |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| within 14 days |
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | In total 110 women participated in the study | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists Physical Status Classification 1 | American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM 1-6.
| Number | participants |
|
| Parity (full term pregnancies) | Median | Full Range | pregnancies |
|
| Previous abdominal surgery | Number | participants |
|
| Subtotal hysterectomy | Number | participants |
|
| American Society of Anesthesiologists Physical Status Classification 2 | Number | participants |
|
| Total hysterectomy | Number | participants |
|
|
|
| Secondary | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation. Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation. Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery. | Posted | Median | Inter-Quartile Range | units on a scale*days | within 14 days |
|
|
|
| Other Pre-specified | Patient-movements | Number of unintended and unwanted patient-movements registered by the surgeon | Not Posted | During surgery |
| 4 |
| 55 |
| 0 |
| 55 |
| EG001 | Moderate Neuromuscular Blockade | Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron placebo | 3 | 55 | 0 | 55 |
| Lesion of the bladder | Renal and urinary disorders | Systematic Assessment |
|
| Vesicovaginal fistula | Renal and urinary disorders | Systematic Assessment |
|
| Postoperative bleeding | Surgical and medical procedures | Systematic Assessment |
|
| hematoma | Surgical and medical procedures | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| VAS incisional pain 4 days AUC |
|
| VAS incisional pain 14 days AUC |
|
| VAS abdominal pain 4 days AUC |
|
| VAS abdominal pain 14 days AUC |
|
| VAS overall pain 4 days AUC |
|
| VAS overall pain 14 days AUC |
|