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NCT05040022

Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure

Status unknown Phase 4 Last updated 20 September 2021
What this trial tests

Phase 4 trial testing Pneumoperitoneum pressure 10 mmHg in Quality of Recovery in 80 participants. Status unknown.

Timeline
1 October 2021
Primary endpoint
5 January 2022
15 January 2022

Quick facts

Lead sponsorPontificia Universidade Catolica de Sao Paulo
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment80
Start date1 October 2021
Primary completion5 January 2022
Estimated completion15 January 2022
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Pontificia Universidade Catolica de Sao Paulo — full company profile →

Who can join

Adults 18 to 70, any sex, with Quality of Recovery or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Deep neuromuscular blockade in adults undergoing an abdominal laparoscopic procedure.
    Bijkerk V, Jacobs LM, Albers KI, Gurusamy KS, et al · · 2024 · cited 2× · PMID 38288876 · DOI 10.1002/14651858.cd013197.pub2

Verify or expand the search:

Other recruiting trials for Quality of Recovery

Currently open trials in the same condition.

Other Pontificia Universidade Catolica de Sao Paulo trials

Trials by the same sponsor.

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Data sources for this page

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