Recovery after laparoscopic removal of the uterus with muscle relaxation and low intraabdominal pressure

Recovery after laparoscopic hysterectomy with deep neuromuscular blockade and low intraabdominal pressure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003787-51-DK

Enrollment

110

Registered

2012-08-23

Start date

2012-10-22

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

The pain study: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions. The safety study: To evaluate the importance of deep neuromuscular blockade (NMB) in laparoscopic hysterectomy considering the number unintended and unwanted patient movements registered by the surgeon.

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 laparoscopic hysterectomy (total/subtotal) 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 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: BMI > 28 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 Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

Design outcomes

Primary

Measure	Time frame
Main Objective: The pain study: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative shoulderpain ;Secondary Objective: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions.;Primary end point(s): Occurrence of shoulder pain or discomfort in the shoulder region within 14 days after operation;Timepoint(s) of evaluation of this end point: 14 days after hysterectomy	—

Measure

Time frame

Main Objective: The pain study: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative shoulderpain ;Secondary Objective: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions.;Primary end point(s): Occurrence of shoulder pain or discomfort in the shoulder region within 14 days after operation;Timepoint(s) of evaluation of this end point: 14 days after hysterectomy

—

Secondary

Measure	Time frame
Secondary end point(s): Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation Number of days before resumption of daily acitivities Number of days before resumption of work ;Timepoint(s) of evaluation of this end point: Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation Number of days before resumption of daily acitivities Number of days before resumption of work	—

Measure

Time frame

Secondary end point(s): Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation Number of days before resumption of daily acitivities Number of days before resumption of work ;Timepoint(s) of evaluation of this end point: Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation Number of days before resumption of daily acitivities Number of days before resumption of work

—

Countries

Denmark

Contacts

Public ContactDepartment of anesthesiology

Mona Ring Gätke

mona.gatke@regionh.dk

Outcome results

None listed

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