Clinical trial NCT06517524: Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
Official title: Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residual Neuromuscular Block
Cardiovascular Diseases
Neuromuscular Blockade Monitoring
Keywords: neuromuscular monitoring
deep neuromuscular blockade
laparoscopic surgery
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Effects of low-pressure pneumoperitoneum associated with deep Pipercuronium-induced neuromuscular blockade on hemodynamic parameters for high cardiovascular risk patients undergoing general anesthesia

Brief 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.

Eligibility criteria: Inclusion Criteria:

* high cardiovascular risk, class III- IV, according to the New York Heart Association classification of heart failure
* Age: between 18- 65 years old.
* ASA (American Society of Anesthesia score) 1- 3
* BMI between 18.5- 25
* Laparoscopic surgical interventions
* Endotracheal intubation
* Patient in supine position on operating table with one arm abducted and accessible.

Exclusion Criteria:

* Patients with diseases affecting neuromuscular functions (myopathies, severe liver and kidney failure).
* Patients on medications affecting the neuromuscular function (magnesium,aminoglycosides).
* Difficult airway or anticipated difficult airway.
* pregnancy (a pregnancy test was performed for every female patient in childbearing age to rule out pregnancy);
* Breastfeeding
* Acute surgical indications
* Chronic Obstructive Pulmonary Disease (COPD)
* Glaucoma

Primary outcomes:
measure: Succes of maintenance low-pressure pneumoperitoneum (6-10 mmHg) during laparascopic surgery
timeFrame: During laporoscopic surgery
Secondary outcomes:
measure: Succes of reversal of deep neuromuscular block mg/kg sugammadex. required.
timeFrame: During laporoscopic surgery
Other outcomes:
measure: Changes in hemodynamic parameters during surgery
timeFrame: During laporoscopic surgery
measure: Changes in Heart rate (beat/min) during surgery
timeFrame: During laporoscopic surgery
measure: The mean arterial pressure recorded (mmHg)
timeFrame: During laporoscopic surgery
measure: Need for pharmacologic circulatory support
timeFrame: During laporoscopic surgery
measure: Quality of the surgical field of view
timeFrame: During laporoscopic surgery
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen
state: hajdu-Bihar
Study officials:
affiliation: Department of Anesthesiology and Intensive Care University of Debrecen
name: Béla Fülesdi, Full professor, Doctor of HAS
role: PRINCIPAL_INVESTIGATOR
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