NCT06517524

Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Tamas Vegh, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Deep neuromuscular block (DNMB) during laparoscopy induces less haemodynamic stress by facilitating low-pressure pneumoperitoneum. the investigators tested the feasibility of pipecuronium-induced deep (post-tetanic count ≥1, train-of-four count = 0) NMB to allow low intraabdominal pressures and maintain cardiovascular stability in patients with low cardiac ejection fraction.MethodsTen adult, NYHA 3-4 surgical patients requiring non-elective abdominal surgery, were included. Pipecuronium bromide (PIPE) 0.09 mg/kg was used for muscle relaxation and maintenance of DNMB. Top-up doses of PIPE were administered when the post-tetanic count was 4-8. Intraabdominal pressures (IAP) were kept below 10 mmHg. Mean arterial pressure (MAP) was measured intra-arterially. Outcome measures used: weight in kilograms, height in meters, need for circulatory suppert (yes/no), success of maintenance (yes/no). Surgical field view was rated on a 5-point scale (1= extremely poor, 5 = optimal)

Detailed description

Patients with a high cardiovascular risk who undergo lparoscopic cholecystectomy before cardiac surgery were included in the study. It is known from the literature that low pressure pneumoperitoneum has less circulatory effects than normal pressure pneumoperitoneum.The abdominal muscles are well relaxed by a deep neuromuscular block using a pypecuronium bromide muscle relaxant. The quality of the surgical field of view is expected to improve. With deep muscle relaxation, low-pressure pneumoperitoneum can be easily maintained, thus the investigators hypothesise that patients will remain haemodynamically stable during surgery. Primary endpoint of the study Maintenance of low-pressure (6-10 mmHg) pneumoperitoneum during surgery using deep NMB with pipecuronium as neuromuscular blocking agent. Secondary endpoint of the study Number of cases with successful reversal of deep neuromuscular block to TOFR ≥0.9 within 3 min after administration of 2 mg/kg sugammadex. Additional endpoints Changes in hemodynamic parameters during surgery, need for pharmacologic circulatory support. Quality of the surgical field of view rated by the surgeon.

Conditions

• Residual Neuromuscular Block
• Cardiovascular Diseases
• Neuromuscular Blockade Monitoring

Timeline

• Start date: 2023-01-08
• Primary completion: 2024-06-05
• Completion: 2024-06-05
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: Hungary