NCT01933425

Brief Summary

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg. Hypothesis: Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 30, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

August 28, 2013

Results QC Date

February 24, 2015

Last Update Submit

March 27, 2015

Conditions

Neuromuscular Blockade

Keywords

surgical conditionslaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Intraabdominal Distance (Centimeters)

    Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).

    1 hour

Secondary Outcomes (2)

  • Intraabdominal Distance (Centimeters)

    1 hour

  • Surgical Conditions During Suturing of the Abdominal Fascia

    1 hour

Study Arms (2)

Deep neuromuscular block followed by no neuromuscular block

ACTIVE COMPARATOR

Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade

Drug: rocuroniumDrug: sugammadexDrug: placebo

No neuromuscular block followed by deep neuromuscular block

PLACEBO COMPARATOR

No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.

Drug: rocuroniumDrug: sugammadexDrug: placebo

Interventions

rocuroniumDRUG
Deep neuromuscular block followed by no neuromuscular blockNo neuromuscular block followed by deep neuromuscular block
sugammadexDRUG
Deep neuromuscular block followed by no neuromuscular blockNo neuromuscular block followed by deep neuromuscular block
placeboDRUG
Deep neuromuscular block followed by no neuromuscular blockNo neuromuscular block followed by deep neuromuscular block

Eligibility Criteria

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

You may qualify if:

  • patients \> 18 years old
  • elective laparoscopic operation
  • can read and understand Danish
  • informed consent

You may not qualify if:

  • BMI \> 30 kg/cm2
  • known allergy to medications that are included in the project,
  • severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis),
  • neuromuscular disease that may interfere with neuromuscular data,
  • lactating or pregnant,
  • impaired liver function,
  • converting to laparotomy,
  • perioperative use of neuromuscular blocking agents before randomization,
  • pneumoperitoneum set to \>12 mmHg on the insufflator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Copenhagen, Søborg, 2830, Denmark

Location

MeSH Terms

Interventions

RocuroniumSugammadex

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Matias Vested Madsen
Organization
Herlev Hospital, University of Copenhagen, Department of Anesthesiology
matias.vested.madsen@regionh.dk
+4538689058

Study Officials

  • Matias Vested Madsen, MD

    Department of Anesthesiology Herlev Hospital

    PRINCIPAL INVESTIGATOR

  • Olav Istre, MD, DMSc, professor

    Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistent, MD

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 30, 2015

Results First Posted

March 30, 2015

Record last verified: 2015-03

Locations

DK(1)