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

NCT01722097 | Completed Phase 4 Results DMC

• 2 other identifiers: NMBDK20122012-003787-51
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain

  Number of participants with shoulder pain or discomfort (VAS \> 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).

  within 14 days

Secondary Outcomes (1)

• Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)

  within 14 days

Other Outcomes (1)

• Patient-movements

  During surgery

Study Arms (2)

Deep neuromuscular blockade

ACTIVE COMPARATOR

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

Drug: Rocuronium

Moderate neuromuscular blockade

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Rocuronium DRUG

Deep neuromuscular blockade

placebo DRUG

Moderate neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective laparoscopic hysterectomy (total/subtotal)
• Can read and understand Danish
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

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

Søborg, 2830, Denmark

Location

Related Publications (2)

• 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.

  PMID: 28552090 DERIVED

• 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.

  PMID: 26479510 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Matias Vested Madsen
• Organization: Herlev Hospital, University of Copenhagen, Department of Anaesthesiology

matias.vested.madsen@regionh.dk

+45 38683868

Study Officials

• Mona Gätke, MD, ph.d.

  Department of anesthesia, Herlev Hospital

  STUDY CHAIR

• Matias Vested Maden, MD

  Department of anesthesia, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistent, MD

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

DK (1)