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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605628
• Other study ID #: NMB Abdomen
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2022
• Source: Kreiskrankenhaus Dormagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Other:
• measuring tape
measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.
• neuromuscular block
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
assessment of operating conditions by means of a standardized score: surgical rating score: extremely poor conditions poor conditions acceptable conditions good conditions optimal conditions

Locations

Country	Name	City	State
Germany	Kreiskrankenhaus Dormagen	Dormagen

Sponsors (1)

Lead Sponsor	Collaborator
Kreiskrankenhaus Dormagen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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