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OpenTrials
Completed

NCT Number: NCT03605628

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

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).

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kreiskrankenhaus Dormagen

Dormagen, D-51375, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

measuring tape

Other

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

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);

Surgical rating score

Other

assessment of operating conditions by means of a standardized score: surgical rating score:

  • extremely poor conditions
  • poor conditions
  • acceptable conditions
  • good conditions
  • optimal conditions

Primary outcomes

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

    Time frame: during operation

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

Secondary outcomes

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

    Time frame: during operation

    assessment of operating conditions by means of a standardized score: surgical rating score (Martini et al. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs. deep neuromuscular block. Br J Anaesth 2014; 112: 498-505:

    • extremely poor conditions
    • poor conditions
    • acceptable conditions
    • good conditions
    • optimal conditions

    The surgical rating score is assessed every 15 min together with abdominal wall length and depth of neuromuscular block

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

    Time frame: during operation

    If a bolus of an analgesic, sedative or neuromuscular blocking agent is required because of inadequate anesthesia during the operation, all measurements mentioned above are performed immediately after the injection of the drug in order to assess the effect of the bolus injection.

Sponsors and collaborators

Lead sponsor

Kreiskrankenhaus Dormagen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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