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

Not Applicable

Completed

• Conditions: Neuromuscular Blockade

• Registration Number: NCT03605628
• Lead Sponsor: Kreiskrankenhaus Dormagen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study Start: 2018-07-01
• Study First Submitted QC: 2018-07-21
• Study First Posted: 2018-07-30
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in abdominal wall length (cm) during time course of the block	during operation	Changes in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.

Secondary Outcome Measures

Name	Time	Method
Change of surgical Rating scale (SRS) scores during neuromuscular block	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: 1. extremely poor conditions; 2. poor conditions; 3. acceptable conditions; 4. good conditions; 5. optimal conditions; The surgical rating score is assessed every 15 min together with abdominal wall length and depth of neuromuscular block
changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents	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.

Trial Locations

Locations (1)

Kreiskrankenhaus Dormagen; 🇩🇪 Dormagen, Germany