FindTrial
Sign In

Quality of recovery and postoperative pain in patients undergoing gallbladder removal laparoscopic surgery under low pneumoperitoneum pressure versus standard pressure with moderate or deep neuromuscular block. Randomized controlled study

Quality of recovery and postoperative pain in patients undergoing laparoscopic cholecystectomy under low pneumoperitoneum pressure versus standard pressure with moderate or deep neuromuscular block. Randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4r4fync
Enrollment
Unknown
Registered
2024-09-16
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum, Artificial

Interventions

Prospective, randomized, double-blinded clinical trial. One hundred and sixty patients aged between 18 and 65 years and physical status ASA I or II, who will be submitted to CL at the Regional hospita
BPP (low pneumoperitoneum pressure and deep NMB)
PPM (standard pneumoperitoneum pressure and moderate BNM) and PPP (standard pneumoperitoneum pressure and deep BNM). No patient, surgeon, anesthesiologist involved in anesthesia control or data collec
E04.210.120.172.140

Sponsors

Faculdade de Medicina de Jundiaí
Lead Sponsor
Hospital Geral do Grajaú
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 65 years; both genders; physical status by the American Society of Anesthesiology I or II; who will undergo Laparoscopic Cholecystectomy at the Regional Hospital of Jundiaí (Jundiaí-SP) performed on an elective basis

Exclusion criteria

Exclusion criteria: Patient refusal; altered level of consciousness or inability to communicate; presence of contraindication to the use of any agent described in the project; history of alcohol or drug abuse; Body Mass Index greater than or equal to 40; presence of chronic pain or opioid use; presence of neuromuscular disease; history of complicated cholelithiasis such as acute cholecystitis, cholangitis, or pancreatitis

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to find a better quality of recovery and less postoperative pain in the group of patients submitted to low pneumoperitoneum pressure with deep muscle relaxation.;Outcome found 1: The use of different pneumoperitoneum pressures under moderate or deep NMB in patients undergoing elective CVL did not alter patients' perception of the quality of postoperative recovery according to the QoR-40 questionnaire.—

Secondary

MeasureTime frame
Expected outcome 2: It is expected that the group with low pneumoperitoneum pressure and deep neuromuscular blockade will have less need for postoperative pain medication rescue and will have less postoperative nausea and vomiting.;Outcome found 2: Patients in the standard pressure and deep NMB groups had greater pain in the 24 hours and a greater need for rescue medication for PONV during hospitalization—

Countries

Brazil

Contacts

Public ContactMarina Fernandes

Faculdade de Medicina de Jundiaí

marina.gasparottof@gmail.com+55 (11) 3395-2100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)