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

NCT ID: NCT02079337

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

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.

Conditions

Surgical Conditions; Rating Scales; Laparoscopy; Neuromuscular Blockade; Pneumoperitoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Deep NMB

Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

sugammadex

Intervention Type: DRUG

placebo

Intervention Type: DRUG

No NMB

Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.

Group Type: PLACEBO_COMPARATOR

Rocuronium

Intervention Type: DRUG

sugammadex

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Interventions

Rocuronium

Intervention Type: DRUG

sugammadex

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matias Vested Madsen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matias V Madsen, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital Department of Anethesiology

Locations

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Søborg, , Denmark

Countries

Denmark

Other Identifiers

NMBVAL2013

Identifier Type: -

Identifier Source: org_study_id