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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular blockade | Active Comparator |
| |
| Moderate neuromuscular blockade | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less | The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space. | From surgical incision to last suture has been placed, an expected average of 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Space Conditions | The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest | From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Surgical Space Conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne K Staehr, MD | Department of anesthesia, Herlev Hospital, Denmark | Principal Investigator |
| Mona R Gätke, MD, Ph.D | Department of anesthesia, Herlev Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet | Soeborg | 2860 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23461992 | Derived | Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Blockade | 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 |
| FG001 | Moderate Neuromuscular Blockade | Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Neuromuscular Blockade | 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 |
| 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 | Median |
| 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 | The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less | The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space. | Posted | Number | percentage of patients | From surgical incision to last suture has been placed, an expected average of 30 minutes |
|
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization | Surgical and medical procedures | Systematic Assessment | Postoperative observation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mona R Gätke, MD, PH.D. | Herlev Hospital | 004538662420 | mona.gatke@regionh.dk |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Rocuronium | Drug | Intravenous use: 0,3 mg/kg followed by NaCl-infusion |
|
|
The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.
| From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Surgical Space Conditions | The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100). | During dissection of the gallbladder |
| Pain | Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery. | Preoperatively to 7 days after surgery |
| Pain | Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery. | At arrival to the postanesthesia care department, 2 hours and 1 day after surgery |
| Normal Functional Level | Numer of days before re-establing normal functional level | from the day of surgery to re-establishing normal functional level - an expected average of 7 days. |
| Surgical Procedures at Low Pneumoperitoneum | Number of procedures which can be done with pneumoperitoneum 8 mmHg | From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Duration of Surgery | Duration of surgery | From surgical incision to last suture has been placed. |
| Duration of Anesthesia | Duration of anesthesia | From induction of anesthesia to patient ready to leave the operating theatre |
| Consumption of Analgesics | Consumption of analgesics during the first 24 hours after surgery | The first 24 hours after surgery |
| Nausea and Vomiting | The incidence of nausea and vomiting during the first 24 hours after surgery | The first 24 hours after surgery |
| Anti-emetics | Use of anti-emetics during the first 24 hours after surgery | During the first 24 hours after surgery |
Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Moderate Neuromuscular Blockade | Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion |
|
|
| Secondary | Surgical Space Conditions | The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest | Not Posted | From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Secondary | Surgical Space Conditions | The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure. | Not Posted | From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Secondary | Surgical Space Conditions | The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100). | Not Posted | During dissection of the gallbladder |
| Secondary | Pain | Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery. | Not Posted | Preoperatively to 7 days after surgery |
| Secondary | Pain | Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery. | Not Posted | At arrival to the postanesthesia care department, 2 hours and 1 day after surgery |
| Secondary | Normal Functional Level | Numer of days before re-establing normal functional level | Not Posted | from the day of surgery to re-establishing normal functional level - an expected average of 7 days. |
| Secondary | Surgical Procedures at Low Pneumoperitoneum | Number of procedures which can be done with pneumoperitoneum 8 mmHg | Not Posted | From surgical incision to last suture has been placed, an expected average of 30 minutes. |
| Secondary | Duration of Surgery | Duration of surgery | Not Posted | From surgical incision to last suture has been placed. |
| Secondary | Duration of Anesthesia | Duration of anesthesia | Not Posted | From induction of anesthesia to patient ready to leave the operating theatre |
| Secondary | Consumption of Analgesics | Consumption of analgesics during the first 24 hours after surgery | Not Posted | The first 24 hours after surgery |
| Secondary | Nausea and Vomiting | The incidence of nausea and vomiting during the first 24 hours after surgery | Not Posted | The first 24 hours after surgery |
| Secondary | Anti-emetics | Use of anti-emetics during the first 24 hours after surgery | Not Posted | During the first 24 hours after surgery |
| 3 |
| 25 |
| 12 |
| 25 |
| EG001 | Moderate Neuromuscular Blockade | Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion | 1 | 23 | 11 | 23 |
|
| Readmission to hospital | Surgical and medical procedures | Systematic Assessment | Undiagnosed gallstones in the common bile duct |
|
| Pain | Surgical and medical procedures | Systematic Assessment |
|
| Headache and vertigo | Surgical and medical procedures |
|
| Bleeding from sutur | Surgical and medical procedures |
|
| hoarseness | Gastrointestinal disorders |
|
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| D011083 |
| Polycyclic Compounds |