- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026530
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
December 4, 2018 updated by: Ebba Kihlstedt Pasquier, Region Östergötland
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective laparoscopic bariatric surgery (LBS)
- American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
- written consent
Exclusion Criteria:
- conversion to open surgery
- complication, Clavien-Dindo grade ≥ II
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulmonary recruitment maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
|
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.
|
Active Comparator: Control group
Ordinary ventilation at the end of laparoscopic bariatric surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain
Time Frame: 4, 12, 24, 36 and 48 hours after surgery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Nausea
Time Frame: 4, 12, 24, 36 and 48 hours after surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebba Kihlstedt Pasquier, MD, Vrinnevi Hospital, Norrköping, Sweden
- Study Chair: Ellen Andersson, MD, PhD, Vrinnevi Hospital, Norrköping, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
January 12, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (Estimate)
January 20, 2017
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Region Östergötland
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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