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Does deep neuromuscular block reduce intra-abdominal pressure requirements during laparoscopic surgery? A prospective observational pilot study

In patients undergoing laparoscopic cholecystectomy surgery, does deep neuromuscular block reduce intra-abdominal pressure requirements?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000961842
Enrollment
20
Registered
2012-09-06
Start date
2013-02-01
Completion date
2013-10-03
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Laparoscopic surgery continues to cause specific pathophysiological changes particularly due to intraabdominal pressure (IAP) and positioning. Cardiovascular changes include hyperand hypotension, prolonged QT dispersion, arrhythmias and rarely cardiac arrest. Splanchnic perfusion changes with changes in organ function are mainly due to the increased intraabdominal pressures and the resultant reduction in abdominal perfusion pressure. Pulmonary changes like hypercarbia, hypoxemia and barotraumas are usually avoided through adaptations in ventilation settings. Although other causes like CO2 absorption, ventilation strategy, surgical technique, the nature and duration of the procedure, and intrinsic patient factors (intravascular volume, preexisting cardiopulmonary status and neurohormonal status) have been identified, the intraabdominal pressure caused by the CO2 pneumoperitoneum combined with the patient’s position remain the main drivers behind these pathophysiological change. Commonly IAP is around 12 mm Hg for most laparoscopic procedures. Pressures above 15 mm Hg lead to increased systemic and pulmonary vascular resistance and a reduction in cardiac index. Lowering insufflation pressures even more leads to a further reduction in postoperative pain and a better quality of life 5 days after surgery. The primary reason for insufflation is to create good view of the surgical field and enough room to manoeuvre with the surgical instrumentation. Determining factors will be the proceduretype dependent extent of the relevant surgical field, the patient habitus, and the abdominal wall elasticity. One would assume that a neuromuscular block (NMB) would facilitate the extension of the abdominal wall and produce more space at lower insufflation pressures. However, only very limited evidence exists, both suggesting that ongoing NMB may or may not provide any benefit. Clinical practice varies between ongoing NMB, intermittent NMB or no NMB at all after induction. With the advent of the reliable NMB reversal agent Sugammadex, we are now in a position to offer continuous deep NMB (CDNMB) until the end of the procedure without compromising our ability to timely and fully reverse the NMB. This enabled us to design this prospective observational pilot study to investigate if the IAP can be reduced to lower values with a CDNMB with Rocuronium compared to no ongoing neuromuscular block under a standardized anaesthetic technique. The outcome of this study will help us determine the power and study size requirements for a randomized controlled trial looking at the lowest IAP in patients with and without continuous deep NMB.

Interventions

This prospective observational pilot study was designed to investigate if the intra-abdominal pressure during laparoscopic cholecystectomy surgery can be reduced to lower values with a continuous deep neuromuscular block with Rocuronium compared to no ongoing neuromuscular block under a standardized anaesthetic technique. This will enable us to estimate (i) the difference (delta) between IAP before and after NMB and (ii) the variance or standard deviation of this difference. Both outcomes are im

This prospective observational pilot study was designed to investigate if the intra-abdominal pressure during laparoscopic cholecystectomy surgery can be reduced to lower values with a continuous deep neuromuscular block with Rocuronium compared to no ongoing neuromuscular block under a standardized anaesthetic technique. This will enable us to estimate (i) the difference (delta) between IAP before and after NMB and (ii) the variance or standard deviation of this difference. Both outcomes are important in designing a future RCT. Please note that both before and after deep neuromuscular block measurements are done in same patient.

Sponsors

Dr Roelof van Wijk
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

More than 18 years old ASA 1-3 Indication for laparoscopic cholecystectomy

Exclusion criteria

Lack of English language skills Psychiatric or mental issues precluding proper informed consent Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026