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

Region Östergötland

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Procedure: Pulmonary recruitment maneuver; Procedure: Laparoscopic bariatric surgery; Device: Ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT03026530

Region Östergötland

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Pulmonary recruitment maneuver

Experimental group

Description:

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

Treatment:

Device: Ventilator

Procedure: Laparoscopic bariatric surgery

Procedure: Pulmonary recruitment maneuver

Control group

Active Comparator group

Description:

Ordinary ventilation at the end of laparoscopic bariatric surgery.

Treatment:

Device: Ventilator

Procedure: Laparoscopic bariatric surgery