Effect of Alveolar Recruitment Maneuver on Postoperative Pain

Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery

Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Alveolar recruitment maneuver

Detailed Description

After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who scheduled for elective bariatric surgery

Exclusion Criteria:

• uncontrolled cardio-vascular disease, active pulmonary disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control; no applying alveolar recuritment maneuver	Procedure: Alveolar recruitment maneuver; Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery; Other Names: Low pressure alveolar recruitment maneuver; High pressure alveolar recruitment maneuver
ACTIVE_COMPARATOR: Low ARM; Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec	Procedure: Alveolar recruitment maneuver; Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery; Other Names: Low pressure alveolar recruitment maneuver; High pressure alveolar recruitment maneuver
ACTIVE_COMPARATOR: High ARM; Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec	Procedure: Alveolar recruitment maneuver; Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery; Other Names: Low pressure alveolar recruitment maneuver; High pressure alveolar recruitment maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale for postoperative pain	score (0 no pain-10 severe pain)	up to postoperative 24 hour
Quality of recovery (QoR40) for Postoperative comfort	score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)	up to postoperative 24 hour

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 25, 2020
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Gil2019-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No