Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure

• Status: Not yet recruiting
• Trial end date: 2022-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The use of low-pressure pneumoperitoneum seems to be able to reduce complications such as postoperative pain. However, the quality of evidence for most studies evaluating this relationship is considered low. The absence of concealment of pneumoperitoneum pressure and the lack of description of neuromuscular blockade characteristics are the main causes of bias. The purpose of this study will be to evaluate by means of a prospective, randomized and double-blinded trial, the quality of recovery (QoR-15) questionnaire of patients undergoing laparoscopic cholecystectomy under moderate neuromuscular blockade, using low pneumoperitoneum pressure or "standard" pressure. Eighty patients submitted to laparoscopic cholecystectomy and randomly distributed in two groups will be included: low pneumoperitoneum pressure (10 mmHg) or "standard" pressure (14 mmHg). The value of abdominal pressure will be kept hidden for all participants, except for the nurse responsible for the operating room. Moderate neuromuscular blockade will be maintained according to Train-of-four count (TOFc) = 3 for all cases.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidade Catolica de Sao Paulo

Criteria

Inclusion Criteria:

• Physical status I and II according to the American Society of Anesthesiologists (ASA)

• Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

• refuse to participate

• Present inability to communicate due to altered level of consciousness or due to the presence of neurological or psychiatric illness

• Present contraindication to the use of any of the drugs employed in the study

• Present history of alcohol or drug addiction

• Body mass index (BMI) ≥ 35

• Presence of chronic pain or use of opioids.