CompletedNot Applicable

Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy

Brazil80 participantsStarted 2019-10-23

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with an ASA physical status I or II, who will be scheduled to undergo LC Exclusion Criteria: * (i) refusal to participate; (ii) altered level of consciousness or inability to communicate; (iii) presented with a contraindication to any of the drugs used in the present study; (iv) history of alcohol or drug abuse; (v) a body mass index (BMI) ≥ 40; (vi) presence of chronic pain or using opioid; (vii) history of complicated gallstone diseases like acute cholecystiitis, cholangitis or pancreatitis. Reasons for exclusion following randomization will include; (i) protocol violations, such as the use of medications not contemplated in the study protocol; (ii) conversion to an open surgical technique

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of recovery

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT04146090

SponsorPontificia Universidade Catolica de Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-06

View on ClinicalTrials.gov More Laparoscopic Surgery trials