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

Study Overview
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Brief Summary
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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).

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

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Other: measuring tape
* Other: neuromuscular block
* Other: Surgical rating score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: abdominal wall length<br>Measurement of abdominal wall length during neuromuscular block with a measuring tape | Other: measuring tape<br>* measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.<br>Other: neuromuscular block<br>* 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);<br>Other: Surgical rating score<br>* assessment of operating conditions by means of a standardized score: surgical rating score: extremely poor conditions poor conditions acceptable conditions good conditions optimal conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of surgical Rating scale (SRS) scores during neuromuscular block | 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 | during operation | 
| changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents | 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. | during operation |