Creating better surgical conditions. Measuring the operating space in the abdomen with and without muscle relaxation

Optimizing surgical conditions: Intraabdominal distance during gynecologic laparoscopic surgery with and without muscle relaxation (The measurement study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001164-29-DK

Enrollment

Registered

2013-05-02

Start date

2013-05-15

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To investigate if deep neuromucular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg. MedDRA version: 14.1 Level: LLT Classification code 10023692 Term: Laparoscopically assisted hysterectomy System Organ Class: 100000004865 MedDRA version: 14.1 Level: LLT Classification code 10023691 Term: Laparoscopic sterilization System Organ Class: 100000004865

Interventions

Trade Name: Esmeron Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ROCURONIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients > 18 years old Elective gynecologic laparoscopy Can read and understand Danish Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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 12 mmHg on the insufflator

Design outcomes

Primary

Measure	Time frame
Main Objective: Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). ;Secondary Objective: Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale. Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). Incidence of incisional hernia 6 months after surgery in group A and B. ;Primary end point(s): Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). ;Timepoint(s) of evaluation of this end point: During operation	—

Measure

Time frame

Main Objective: Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). ;Secondary Objective: Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale. Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). Incidence of incisional hernia 6 months after surgery in group A and B. ;Primary end point(s): Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). ;Timepoint(s) of evaluation of this end point: During operation

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Secondary

Measure	Time frame
Secondary end point(s): Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale. Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). Incidence of incisional hernia 6 months after surgery in group A and B. ;Timepoint(s) of evaluation of this end point: During operation and 6 months after operation	—

Measure

Time frame

Secondary end point(s): Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale. Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). Incidence of incisional hernia 6 months after surgery in group A and B. ;Timepoint(s) of evaluation of this end point: During operation and 6 months after operation

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Countries

Denmark

Contacts

Public ContactMona Ring Gätke

Department of anesthesiology

mona.gatke@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026