Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations

NCT03605628 | Completed

• 1 other identifier: NMB Abdomen
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromuscular block improves operation conditions during laparoscopic surgery. In this study, a new measurement tool is assessed: the degree of abdominal distension during the time course of the neuromuscular block is measured and compared with a standardized score (surgical rating score).

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• change in abdominal wall length (cm) during time course of the block

  Changes in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.

  during operation

Secondary Outcomes (2)

• Change of surgical Rating scale (SRS) scores during neuromuscular block

  during operation

• changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents

  during operation

Study Arms (1)

abdominal wall length

OTHER

Measurement of abdominal wall length during neuromuscular block with a measuring tape

Other: measuring tape; Other: neuromuscular block; Other: Surgical rating score

Interventions

measuring tape OTHER

measurement of change in abdominal wall length \[cm\] during neuromuscular block with a measuring tape.

abdominal wall length

neuromuscular block OTHER

Measurement of the time course of the neuromuscular block: neuromuscular transmission is measured by assessment of the post tetanic count and the train of four ratio using acceleromyography (TOF Watch SX™, Essex Pharma GmbH, Munich, Germany) at the right adductor pollicis muscle with transcutaneous Ag/AgCl electrodes (electrocardiogram electrodes; Ambu Inc., MD 21060 USA);

abdominal wall length

Surgical rating score OTHER

assessment of operating conditions by means of a standardized score: surgical rating score: 1. extremely poor conditions 2. poor conditions 3. acceptable conditions 4. good conditions 5. optimal conditions

abdominal wall length

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• laparoscopic gynecologic surgery
• American Society of Anesthesiologists Physical Status ASA 1-2

You may not qualify if:

• anticipated difficult airway
• increased risk for pulmonary aspiration
• acute infection
• pregnancy
• impaired liver- oder kidney function
• neuromuscular disease
• chronic intake of drugs known to influence neuromuscular blockade

Sponsors & Collaborators

• Kreiskrankenhaus Dormagen: lead

Study Sites (1)

Kreiskrankenhaus Dormagen

Dormagen, D-51375, Germany

Location

MeSH Terms

Interventions

Neuromuscular Blockade

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques

Study Officials

• Stefan Soltesz, MD

  Kreiskrankenhaus Dormagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Assessment of the quality of operation conditions by the obstretic surgeon without information with regard to the actual depth of the neuromuscular block or the drugs administrated for improvement of the block.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: July 30, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

DE (1)