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

NCT06517524 | Completed DMC

• 3 other identifiers: AITT/2022/6OGYEI/3968-1/2023DE RKEB/IKEB:6252-2022
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Residual Neuromuscular Block; Cardiovascular Diseases; Neuromuscular Blockade Monitoring

Keywords

neuromuscular monitoring; deep neuromuscular blockade; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  During laporoscopic surgery

Other Outcomes (5)

• Changes in hemodynamic parameters during surgery

  During laporoscopic surgery

• Changes in Heart rate (beat/min) during surgery

  During laporoscopic surgery

• The mean arterial pressure recorded (mmHg)

  During laporoscopic surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (19)

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  PMID: 39983904 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Béla Fülesdi, Full professor, Doctor of HAS

  Department of Anesthesiology and Intensive Care University of Debrecen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of General, Vascular and Thoracic Anesthesia

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 24, 2024
• Study Start: January 8, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

HU (1)