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

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ClinicalTrials.gov Identifier: NCT02079337
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Matias Vested Madsen, Herlev Hospital

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.


Condition or disease Intervention/treatment Phase
Surgical Conditions Rating Scales Laparoscopy Neuromuscular Blockade Pneumoperitoneum Drug: Rocuronium Drug: sugammadex Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Active Comparator: Deep NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
Drug: Rocuronium
Drug: sugammadex
Drug: placebo
Placebo Comparator: No NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
Drug: Rocuronium
Drug: sugammadex
Drug: placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079337


Locations
Denmark
Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
Søborg, Denmark, 2860
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Matias V Madsen, MD Herlev Hospital Department of Anethesiology

Responsible Party: Matias Vested Madsen, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02079337     History of Changes
Other Study ID Numbers: NMBVAL2013
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Disease
Pneumoperitoneum
Pathologic Processes
Peritoneal Diseases
Digestive System Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs