Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
NCT Number: NCT06517524
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Residual Neuromuscular Block|Cardiovascular Diseases|Neuromuscular Blockade Monitoring
Sponsor: Tamas Vegh, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-08
Completion Date: 2024-06-05
Locations: University of Debrecen, Debrecen, hajdu-Bihar, 4032, Hungary

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)

Primary Outcome Measures: Succes of maintenance low-pressure pneumoperitoneum (6-10 mmHg) during laparascopic surgery, Succes of maintenance of low-pressure (6-10 mmHg) pneumoperitoneum during surgery using deep NMB with pipecuronium as neuromuscular blocking agent (yes/no).

Pneumoperitoneum pressure will be registered continously throughout the study. The threshold for low IAP is predefined. The maintenance of low IAP will be assessed off-line (yes/no) as well as the IAP values as absolute numbers will be analized. If the intra-abdominal pressure is within this range (6-10 mmHg), maintenance of low-pressure pneumoperitoneum is considered successful (yes). Otherwise, maintaining a low-pressure pneumoperitoneum will prove unsuccessful., During laporoscopic surgery
Secondary Outcome Measures: Succes of reversal of deep neuromuscular block mg/kg sugammadex. required., Succes of reversal of deep neuromuscular block to TOFR ≥0.9 within 3 min after administration of 2 mg/kg sugammadex (yes/no). Reversal is considered successful (yes) if the time from administration of sugammadex to TOFR0.9 is less than 3 minutes. If this time is more than 3 minutes, the reversal is considered unsuccessful (no)., During laporoscopic surgery
Other Outcome Measures: Changes in hemodynamic parameters during surgery, Changes in hemodynamic parameters during surgery: invasive arterial blood pressure measurement is used to measure the patient's systolic and diastolic blood pressure values (mmHg). Patients are considered haemodynamically stable if these values remain within 15% of baseline., During laporoscopic surgery|Changes in Heart rate (beat/min) during surgery, Changes in hemodynamic parameters during surgery. Patients are considered haemodynamically stable if these values remain within 15% of baseline., During laporoscopic surgery|The mean arterial pressure recorded (mmHg), Patients are considered haemodynamically stable if these values remain within 15% of baseline., During laporoscopic surgery|Need for pharmacologic circulatory support, The need for catecholamine administration during surgery: yes or no, During laporoscopic surgery|Quality of the surgical field of view, Quality of the surgical field of view rated by the surgeon. We use five- point scale according to Baete et. al. study from 2017.

The operating surgeon can choose between 1 to 5 according to the quality of the surgical field, where 1= very bad, 2=bad, 3= acceptable, 4 =good, 5=optimal.

We record the score chosen by the surgeon., During laporoscopic surgery