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NCT05040022
Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure
Phase 4 trial testing Pneumoperitoneum pressure 10 mmHg in Quality of Recovery in 80 participants. Status unknown.
5 January 2022
Quick facts
| Lead sponsor | Pontificia Universidade Catolica de Sao Paulo |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 1 October 2021 |
| Primary completion | 5 January 2022 |
| Estimated completion | 15 January 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Pneumoperitoneum pressure 10 mmHg — full drug profile →
- Pneumoperitoneum pressure 14 mmHg — full drug profile →
Conditions studied
- Quality of Recovery — all drugs for Quality of Recovery →
- Postoperative Pain — all drugs for Postoperative Pain →
- Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →
- Neuromuscular Blockade — all drugs for Neuromuscular Blockade →
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):
-
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:
- PubMed search for NCT05040022
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Quality of Recovery
Currently open trials in the same condition.
- NCT06584825 — Enhanced Vitals Monitoring After Major Surgery Trial · NA · recruiting
- NCT06948383 — SPSIPB vs. SAPB in Breast Surgery · NA · active not recruiting
Other Pontificia Universidade Catolica de Sao Paulo trials
Trials by the same sponsor.
- NCT05053594 — Different Doses of Neostigmine for Reversal of Moderate Neuromuscular Blockade in Children · Phase 4 · unknown
- NCT05037006 — Three Different Doses of Neostigmine on the Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade · Phase 4 · unknown
- NCT04920682 — Reversal of Moderate or Superficial Neuromuscular Blockade Induced by Cisatracurium · Phase 4 · completed
- NCT04146090 — Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy · NA · completed
- NCT03035942 — Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05040022 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pontificia Universidade Catolica de Sao Paulo
- Last refreshed: 20 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05040022.
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