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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03605628
Enrollment
50
Registered
2018-07-30
Start date
2018-07-01
Completion date
2019-06-30
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

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).

Interventions

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

OTHERneuromuscular 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);

OTHERSurgical rating score

assessment of operating conditions by means of a standardized score: surgical rating score: 1. extremely poor conditions 2. poor conditions 3. acceptable conditions 4. good conditions 5. optimal conditions

Sponsors

Kreiskrankenhaus Dormagen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Assessment of the quality of operation conditions by the obstretic surgeon without information with regard to the actual depth of the neuromuscular block or the drugs administrated for improvement of the block.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in abdominal wall length (cm) during time course of the blockduring operationChanges in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.

Secondary

MeasureTime frameDescription
Change of surgical Rating scale (SRS) scores during neuromuscular blockduring operationassessment 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 agentsduring operationIf 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026