ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000961842

Ethics application status

Approved

Date submitted

5/09/2012

Date registered

6/09/2012

Date last updated

28/10/2024

Date data sharing statement initially provided

28/10/2024

Date results provided

28/10/2024

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]

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intra-abdominal pressure during laparoscopic cholecystectomy surgery

Minimally required intra-abdominal pressure for adequate surgical exposure/view during laparoscopic cholecystectomy surgery

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

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]

Not applicable

Comparator / control treatment

Prospective open pilot study; no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Lowest acceptable continuous intra-abdominal pressure (IAP cm H2O) derived from the inflation device.

Timepoint [1]

before and after administration of rocuronium

Secondary outcome [1]

Patient age, gender, weight, length, and BMI

Timepoint [1]

Baseline (before surgery)

Secondary outcome [2]

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]

Every 15 min throughout the surgery

Secondary outcome [3]

Exposure Rating: 1 (excellent) to 3 (poor)

Timepoint [3]

before and after administration of rocuronium

Secondary outcome [4]

Level of Surgical Expertise: Registrar; Fellow; Consultant

Timepoint [4]

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?

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

Completed

Date of first participant enrolment

Anticipated

1/02/2013

Actual

1/02/2013

Date of last participant enrolment

Anticipated

Actual

3/10/2013

Date of last data collection

Anticipated

Actual

3/10/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Queen Elizabeth Hospital Anaesthesia Clinical Research Fund

Address [1]

The Queen Elizabeth HospitalWoodville Road
Woodville South SA 5011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (TQEH/LMH/MH) (EC00190)

Ethics committee address [1]

TQEH
Woodville Road
Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/09/2012

Approval date [1]

14/12/2012

Ethics approval number [1]

HREC/12/TQEHLMH/130

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

A/Prof Roelof M. VAN WIJK

Address

Dept of Anaesthesia
The Queen Elizabeth Hospital
Woodville Rd
Woodville South SA 5011

Country

Australia

Phone

+61871014356

Fax

roelof.vanwijk@sa.gov.au

Contact person for public queries

Name

Roelof van Wijk

Address

Dr Roelof van Wijk
Head of Dept of Anaesthesia
TQEH
Woodville Road
Woodville South SA 5011

Country

Australia

Phone

+61871014356

Fax

roelof.vanwijk@sa.gov.au

Contact person for scientific queries

Name

Roelof van Wijk

Address

Dr Roelof van Wijk
Head of Dept of Anaesthesia
TQEH
Woodville Road
Woodville South SA 5011

Country

Australia

Phone

+61871014356

Fax

+61882227065

roelof.vanwijk@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23819	Other	Publication				362991-(Uploaded-09-09-2024-15-23-56)-aas12491.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: A prospective observational study.	2015	https://dx.doi.org/10.1111/aas.12491

N.B. These documents automatically identified may not have been verified by the study sponsor.

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