NCT03726372

Brief Summary

During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 28, 2018

Last Update Submit

October 29, 2018

Conditions

General AnesthesiaPostoperative Complications

Keywords

robotic surgerylaparoscopic surgeryneuromuscular blockadepostoperative complication

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative major respiratory complications

    incidence of pneumonia and atelectasis

    from end of surgery to discharge, at an average of 4 days

Secondary Outcomes (11)

  • maximal airway pressure

    from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours

  • minimal cerebral oxygen saturation

    from start of surgery to end of surgery, at an average of 3.5 hours

  • maximal intraocular pressure

    from start of surgery to end of surgery, at an average of 3.5 hours

  • number of surgeon asking for improving muscle relax

    from start of surgery to end of surgery, at an average of 3.5 hours

  • time to extubation

    from end of sevoflurane inhalation to extubation, at an average of 20 minutes

  • +6 more secondary outcomes

Study Arms (2)

deep neuromuscular blockade

EXPERIMENTAL

Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero

Drug: RocuroniumOther: continuous infusion

moderate neuromuscular blockade

EXPERIMENTAL

Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2

Drug: RocuroniumOther: intermittent injection

Interventions

RocuroniumDRUG

rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

Also known as: rocuronium bromide
deep neuromuscular blockademoderate neuromuscular blockade
continuous infusionOTHER

rocuronium is continuously infused

Also known as: high dose
deep neuromuscular blockade
intermittent injectionOTHER

rocuronium is intermittently given

Also known as: low dose
moderate neuromuscular blockade

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for elective robotic laparoscopic surgery under general anesthesia
  • American Society of Anesthesiologists status 1-2
  • Body mass index of 18-30kg/m2
  • Patients scheduled to be positioned in trendelenburg position during surgery

You may not qualify if:

  • Patients allergic to rocuronium
  • Patients with neuromuscular dysfunction
  • Patients with existed pulmonary diseases
  • Patients with hepatic or renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.

    PMID: 25684372BACKGROUND

  • Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

    PMID: 24240315BACKGROUND

  • Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.

    PMID: 28803124BACKGROUND

  • Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.

    PMID: 27936214BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

RocuroniumContraceptives, Oral

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Zhihong Lu

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018deerlu23@163.com

Hailong Dong

CONTACT

86-84775337hldong6@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 28, 2018

First Posted

October 31, 2018

Study Start

November 10, 2018

Primary Completion

November 10, 2019

Study Completion

November 10, 2019

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

After publishing, data of the primary endpoint and second endpoints can be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
When the results have been published in peer-reviewed journals, the data will be available. The planned time frame will be 5 years.