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The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary recruitment maneuver | Experimental | Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. |
|
| Control group | Active Comparator | Ordinary ventilation at the end of laparoscopic bariatric surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary recruitment maneuver | Procedure | The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain. | 4, 12, 24, 36 and 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Nausea | A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea. | 4, 12, 24, 36 and 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebba Kihlstedt Pasquier, MD | Vrinnevi Hospital, Norrköping, Sweden | Principal Investigator |
| Ellen Andersson, MD, PhD | Vrinnevi Hospital, Norrköping, Sweden | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29290563 | Result | Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Recruitment Maneuver | Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
| FG001 | Control Group | Ordinary ventilation at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Recruitment Maneuver | Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
| 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 | Postoperative Pain | A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain. | Posted | Median | Inter-Quartile Range | score on a scale | 4, 12, 24, 36 and 48 hours after surgery |
|
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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 | Pulmonary Recruitment Maneuver | Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kihlstedt Pasquier | Region Ostergotland | 0046101041000 | ebba.kihlstedt.pasquier@regionostergotland.se |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012122 | Ventilators, Mechanical |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Laparoscopic bariatric surgery | Procedure |
|
| Ventilator | Device |
|
| BG001 | Control Group | Ordinary ventilation at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| Control Group |
Ordinary ventilation at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator |
|
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| Secondary | Postoperative Nausea | A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea. | Posted | Median | Inter-Quartile Range | score on a scale | 4, 12, 24, 36 and 48 hours after surgery |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Control Group | Ordinary ventilation at the end of laparoscopic bariatric surgery. Laparoscopic bariatric surgery Ventilator | 0 | 100 | 0 | 100 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| 24 hr |
|
| 36 hr |
|
| 48 hr |
|