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

Herlev Hospital

Status and phase

Completed

Phase 4

Conditions

Rating Scales

Laparoscopy

Pneumoperitoneum

Surgical Conditions

Neuromuscular Blockade

Treatments

Drug: sugammadex

Drug: placebo

Drug: Rocuronium

Study type

Interventional

Funder types

Other

Identifiers

NCT02079337

NMBVAL2013

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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