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

Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions During Gynecologic 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).

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Other: measuring tape; Other: neuromuscular block; Other: Surgical rating score

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dormagen, Germany, D-51375
    • Kreiskrankenhaus Dormagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kreiskrankenhaus Dormagen
• Investigators: Principal Investigator: Stefan Soltesz, MD, Kreiskrankenhaus Dormagen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: NMB Abdomen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No