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Completed

NCT Number: NCT02079337

Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery

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.

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Key information

Conditions

Surgical Conditions Digestive System Diseases Laparoscopy Neuromuscular Blockade Peritoneal Diseases Pneumoperitoneum Rating Scales

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Søborg, 2860, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Sugammadex

Drug

Placebo

Drug

Primary outcomes

  1. Subjective rating scale

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

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

Secondary outcomes

  1. Number of correct estimates of level of NMB

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

  2. Number of correct estimates of level of NMB according to grade of surgical experience

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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2014
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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