Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000961842
Ethics application status
Not yet submitted
Date submitted
5/09/2012
Date registered
6/09/2012
Date last updated
6/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does deep neuromuscular block reduce intra-abdominal pressure requirements during laparoscopic surgery? A prospective observational pilot study
Scientific title
In patients undergoing laparoscopic cholecystectomy surgery, does deep neuromuscular block reduce intra-abdominal pressure requirements?
Secondary ID [1] 281170 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra-abdominal pressure during laparoscopic cholecystectomy surgery 287337 0
Minimally required intra-abdominal pressure for adequate surgical exposure/view during laparoscopic cholecystectomy surgery 287338 0
Condition category
Condition code
Anaesthesiology 287674 287674 0 0
Anaesthetics
Surgery 287677 287677 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 285618 0
Not applicable
Comparator / control treatment
Prospective open pilot study; no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287915 0
Lowest acceptable continuous intra-abdominal pressure (IAP cm H2O) derived from the inflation device.
Timepoint [1] 287915 0
before and after administration of rocuronium
Secondary outcome [1] 299047 0
Patient age, gender, weight, length, and BMI
Timepoint [1] 299047 0
Baseline (before surgery)
Secondary outcome [2] 299048 0
Max plateau and peek airway pressures at standardized ventilation settings (50% O2 in air; 5 PEEP; I:E=1:1.5; Respiratory Rate 12; target etCO2 at between 35 and 40 cmHg)
Timepoint [2] 299048 0
Every 15 min throughout the surgery
Secondary outcome [3] 299049 0
Exposure Rating: 1 (excellent) to 3 (poor)
Timepoint [3] 299049 0
before and after administration of rocuronium
Secondary outcome [4] 299050 0
Level of Surgical Expertise: Registrar; Fellow; Consultant
Timepoint [4] 299050 0
at the time of surgery

Eligibility
Key inclusion criteria
More than 18 years old
ASA 1-3
Indication for laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of English language skills
Psychiatric or mental issues precluding proper informed consent
Pregnancy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285943 0
Hospital
Name [1] 285943 0
The Queen Elizabeth Hospital Anaesthesia Clinical Research Fund
Country [1] 285943 0
Australia
Primary sponsor type
Individual
Name
Dr Roelof van Wijk
Address
Department of Anaesthesia
The Queen Elizabeth Hospital
Woodville Road
Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 284767 0
None
Name [1] 284767 0
Address [1] 284767 0
Country [1] 284767 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287975 0
Human Research Ethics Committee (TQEH/LMH/MH) (EC00190)
Ethics committee address [1] 287975 0
TQEH
Woodville Road
Woodville South SA 5011
Ethics committee country [1] 287975 0
Australia
Date submitted for ethics approval [1] 287975 0
15/09/2012
Approval date [1] 287975 0
Ethics approval number [1] 287975 0

Summary
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.
Trial website
NA
Trial related presentations / publications
Watts RW, London JA, van Wijk RMAW, Lui YL.
The influence of unrestricted use of sugammadex on clinical
anaesthetic practice in a tertiary teaching hospital. Anaesthesia & Intensive Care. 2012. 40(2):3339
Public notes

Contacts
Principal investigator
Name 34669 0
Address 34669 0
Country 34669 0
Phone 34669 0
Fax 34669 0
Email 34669 0
Contact person for public queries
Name 17916 0
Roelof van Wijk
Address 17916 0
Dr Roelof van Wijk
Head of Dept of Anaesthesia
TQEH
Woodville Road
Woodville South SA 5011
Country 17916 0
Australia
Phone 17916 0
+61882226640
Fax 17916 0
+61882227065
Email 17916 0
roelof.vanwijk@health.sa.gov.au
Contact person for scientific queries
Name 8844 0
Roelof van Wijk
Address 8844 0
Dr Roelof van Wijk
Head of Dept of Anaesthesia
TQEH
Woodville Road
Woodville South SA 5011
Country 8844 0
Australia
Phone 8844 0
+61882226640
Fax 8844 0
+61882227065
Email 8844 0
roelof.vanwijk@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23819Other   

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4378Study results articleYes Deep neuromuscular block reduces intra-abdominal p... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDeep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: A prospective observational study.2015https://dx.doi.org/10.1111/aas.12491
N.B. These documents automatically identified may not have been verified by the study sponsor.