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

Phase 4

Completed

• Conditions: Surgical Conditions; Rating Scales; Pneumoperitoneum; Laparoscopy; Neuromuscular Blockade
• Interventions: Drug: Rocuronium; Drug: sugammadex; Drug: placebo

• Registration Number: NCT02079337
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deep NMB	placebo	Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
No NMB	placebo	Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
Deep NMB	Rocuronium	Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
Deep NMB	sugammadex	Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
No NMB	Rocuronium	Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
No NMB	sugammadex	Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
Subjective rating scale	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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital; 🇩🇰 Søborg, Denmark