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

Region Östergötland

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Procedure: Pulmonary Recruitment Maneuver; Device: Ventilator; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03026543

Regionostergotland

Details and patient eligibility

About

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective laparoscopic cholecystectomy
• American Society of Anesthesiologists (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
• Clavien-Dindo grade ≥ II

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Pulmonary recruitment maneuver

Experimental group

Description:

One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.

Treatment:

Procedure: Laparoscopic cholecystectomy

Procedure: Pulmonary Recruitment Maneuver

Device: Ventilator

Control group

Active Comparator group

Description:

Ordinary ventilation at the end of laparoscopic cholecystectomy.

Treatment:

Procedure: Laparoscopic cholecystectomy

Device: Ventilator