Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure

NCT ID: NCT01722097

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-07-31

Brief Summary

The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).

Conditions

Neuromuscular Blockade; Pain; Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Deep neuromuscular blockade

Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

Moderate neuromuscular blockade

Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Rocuronium

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Elective laparoscopic hysterectomy (total/subtotal)
• 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
• Impaired liver function
• Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

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

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matias Vested Madsen

research assistent, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Gätke, MD, ph.d.

Role: STUDY_CHAIR

Department of anesthesia, Herlev Hospital

Matias Vested Maden, MD

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia, Herlev Hospital

Locations

Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet

Søborg, , Denmark

Countries

Denmark

References

Madsen MV, Istre O, Springborg HH, Staehr-Rye AK, Rosenberg J, Lund J, Gatke MR. Deep neuromuscular blockade and low insufflation pressure during laparoscopic hysterectomy. Dan Med J. 2017 May;64(5):A5364.

Reference Type: DERIVED

PMID: 28552090 (View on PubMed)

Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.

Reference Type: DERIVED

PMID: 26479510 (View on PubMed)

Other Identifiers

2012-003787-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NMBDK2012

Identifier Type: -

Identifier Source: org_study_id