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

July 8, 2014 updated by: Matias Vested Madsen, Herlev Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Søborg, Denmark, 2860
        • Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Evaluation of video images within a time frame of in average 5 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Matias V Madsen, MD, Herlev Hospital Department of Anethesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMBVAL2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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