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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079337
• Other study ID #: NMBVAL2013
• 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)

Related Conditions & MeSH terms

• Disease
• Laparoscopy
• Neuromuscular Blockade
• Pneumoperitoneum
• Rating Scales
• Surgical Conditions

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