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Completed

NCT Number: NCT06517524

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

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)

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Key information

Conditions

Residual Neuromuscular Block Cardiovascular Diseases Delayed Emergence from Anesthesia Neuromuscular Blockade Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Succes of maintenance low-pressure pneumoperitoneum (6-10 mmHg) during laparascopic surgery

    Time frame: During laporoscopic 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.

Secondary outcomes

  1. Succes of reversal of deep neuromuscular block mg/kg sugammadex. required.

    Time frame: During laporoscopic surgery

    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).

Other outcomes

  1. Changes in hemodynamic parameters during surgery

    Time frame: During laporoscopic 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.

  2. Changes in Heart rate (beat/min) during surgery

    Time frame: During laporoscopic surgery

    Changes in hemodynamic parameters during surgery. Patients are considered haemodynamically stable if these values remain within 15% of baseline.

  3. The mean arterial pressure recorded (mmHg)

    Time frame: During laporoscopic surgery

    Patients are considered haemodynamically stable if these values remain within 15% of baseline.

  4. Need for pharmacologic circulatory support

    Time frame: During laporoscopic surgery

    The need for catecholamine administration during surgery: yes or no

  5. Quality of the surgical field of view

    Time frame: During laporoscopic surgery

    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.

Sponsors and collaborators

Lead sponsor

Tamas Vegh, MD

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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