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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02079337
Other study ID # NMBVAL2013
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2014
Last updated July 8, 2014
Start date November 2013
Est. completion date April 2014

Study information

Verified date July 2014
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients > 18 years old

- elective gynecologic laparoscopic operation

- can read and understand Danish

- informed consent

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)


Intervention

Drug:
Rocuronium

sugammadex

placebo


Locations

Country Name City State
Denmark Department of minimal invasive gynecology Aleris-Hamlet Private Hospital Søborg

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Number of correct estimates of level of NMB Evaluation of video images within a time frame of in average 5 months after surgery No
Secondary 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 No
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