NCT02079337

Brief Summary

Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described. Purpose: The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.

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 Nov 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

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
27 days 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
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

February 26, 2014

Last Update Submit

July 8, 2014

Conditions

Surgical ConditionsRating ScalesLaparoscopyNeuromuscular BlockadePneumoperitoneum

Outcome Measures

Primary Outcomes (1)

  • Subjective rating scale

    The subjective rating scale with best possible interobserver agreement described by kappa statistics

    Evaluation of video images within a time frame of in average 5 months after surgery

Secondary Outcomes (2)

  • Number of correct estimates of level of NMB

    Evaluation of video images within a time frame of in average 5 months after surgery

  • Number of correct estimates of level of NMB according to grade of surgical experience

    Evaluation of video images within a time frame of in average 5 months after surgery

Study Arms (2)

Deep NMB

ACTIVE COMPARATOR

Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade

Drug: RocuroniumDrug: sugammadexDrug: placebo

No NMB

PLACEBO COMPARATOR

Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.

Drug: RocuroniumDrug: sugammadexDrug: placebo

Interventions

RocuroniumDRUG
Deep NMBNo NMB
sugammadexDRUG
Deep NMBNo NMB
placeboDRUG
Deep NMBNo NMB

Eligibility Criteria

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

You may qualify if:

  • patients \> 18 years old
  • elective gynecologic 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

Søborg, 2860, Denmark

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

RocuroniumSugammadex

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Matias V Madsen, MD

    Herlev Hospital Department of Anethesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 5, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

DK(1)