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

July 23, 2024 updated by: Tamas Vegh, MD

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)

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • hajdu-Bihar
      • Debrecen, hajdu-Bihar, Hungary, 4032
        • University of Debrecen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During laporoscopic surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During laporoscopic surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During laporoscopic surgery
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.
During laporoscopic surgery
The mean arterial pressure recorded (mmHg)
Time Frame: During laporoscopic surgery
Patients are considered haemodynamically stable if these values remain within 15% of baseline.
During laporoscopic surgery
Need for pharmacologic circulatory support
Time Frame: During laporoscopic surgery
The need for catecholamine administration during surgery: yes or no
During laporoscopic surgery
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.
During laporoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tamas Vegh, MD

Investigators

  • Principal Investigator: Béla Fülesdi, Full professor, Doctor of HAS, Department of Anesthesiology and Intensive Care University of Debrecen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2023

Primary Completion (Actual)

June 5, 2024

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AITT/2022/6
  • OGYEI/3968-1/2023 (Other Identifier: National Institute of Pharmacy and Nutrition)
  • DE RKEB/IKEB:6252-2022 (Other Identifier: Regional and Institutional Ethics Committee University of Debrecen Clinical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe