Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Pain, Postoperative Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pulmonary recruitment maneuver

Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.

Group Type EXPERIMENTAL

Pulmonary recruitment maneuver

Intervention Type 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.

Laparoscopic bariatric surgery

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Control group

Ordinary ventilation at the end of laparoscopic bariatric surgery.

Group Type ACTIVE_COMPARATOR

Laparoscopic bariatric surgery

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Interventions

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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.

Intervention Type PROCEDURE

Laparoscopic bariatric surgery

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Eligibility Criteria

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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