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Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure

NCT05040022 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-20

No results posted yet for this study

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.

Conditions

  • Quality of Recovery
  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Neuromuscular Blockade

Interventions

DRUG

Pneumoperitoneum pressure 10 mmHg

The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 10 mmHg (group 10)

DRUG

Pneumoperitoneum pressure 14 mmHg

The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 14 mmHg (group 14).

Sponsors & Collaborators

  • Pontificia Universidade Catolica de Sao Paulo

    lead OTHER

Principal Investigators

  • Eduardo Moro · Faculdade de Ciências Médicas e da Saúde PUCSP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-01-05
Completion
2022-01-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040022 on ClinicalTrials.gov