Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Succes of maintenance low-pressure pneumoperitoneum (6-10 mmHg) during laparascopic surgery
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Succes of reversal of deep neuromuscular block mg/kg sugammadex. required.(During laporoscopic surgery)
Investigators
Tamas Vegh, MD
Head, Division of General, Vascular and Thoracic Anesthesia
University of Debrecen