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

NCT ID: NCT06517524

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-08
• Study Completion Date: 2024-06-05

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.

Conditions

Residual Neuromuscular Block; Cardiovascular Diseases; Neuromuscular Blockade Monitoring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tamas Vegh, MD

OTHER

Sponsor Role: lead

Responsible Party

Tamas Vegh, MD

Head, Division of General, Vascular and Thoracic Anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Béla Fülesdi, Full professor, Doctor of HAS

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care University of Debrecen

Locations

University of Debrecen

Debrecen, Hajdú-Bihar, Hungary

Countries

Hungary

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Other Identifiers

OGYEI/3968-1/2023

Identifier Type: OTHER

Identifier Source: secondary_id

DE RKEB/IKEB:6252-2022

Identifier Type: OTHER

Identifier Source: secondary_id

AITT/2022/6

Identifier Type: -

Identifier Source: org_study_id