MedTrace Logo

Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy

NCT04146090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-04-02

No results posted yet for this study

Summary

Background. Many studies have demonstrated reduced postoperative pain in patients undergoing lower pneumoperitoneum pressure level during laparoscopic cholecystectomy. However, most of them has shown a high risk of bias and low or very low quality of evidence. Considering the need to evaluate, not only the postoperative pain, but the effect of anesthesia and surgery on patient recovery and satisfaction, we have designed a prospective, randomised and double-blinded study to evaluate the quality of recovery, using the Quality of Recovery Questionnaire (QoR-40), in patients undergoing LC under low-pressure or standard pressure pneumoperitoneum. Methods. Eighty patients aged 18 to 65 years of age will be randomised into 2 groups: LP (low-pressure - 10mmHg) or S (standard - 14 mmHg) enrolled in the study. Anesthesia will be induced with remifentanil, propofol and rocuronium and the maintenance will be achieved with sevoflurane and remifentanil Anesthesiologists and surgeons will not have access to insufflation pressure display. The primary outcome will be assessed using the Quality of Recovery Questionnaire (QoR-40) which is a 40-item quality of recovery scoring system. In addition, the intraoperative rocuronium consumption, time to eye opening (time from the discontinuation of anesthetics to eye opening), post-operative nausea and vomiting, pain score, analgesic use, and length of PACU stay (time to Aldrete score ≥ 9) will be recorded.

Conditions

  • Laparoscopic Surgery
  • Pneumoperitoneum
  • Cholecystitis; Choledocholithiasis
  • Quality of Life
  • Postoperative Nausea and Vomiting
  • Postoperative Pain
  • Satisfaction, Patient

Interventions

OTHER

Low-pressure pneumoperitoneum

Pneumoperitoneum will be maintained in 10 mmHg

OTHER

Standard pressure pneumoperitoneum

Pneumoperitoneum will be maintained in 14 mmHg

Sponsors & Collaborators

  • Pontificia Universidade Catolica de Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2021-01-06
Completion
2021-02-10

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT04146090 on ClinicalTrials.gov