Neuromuscular BlockadeNCT03605628
Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations
A study testing measuring tape, neuromuscular block and Surgical rating score in people with Neuromuscular Blockade, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- measuring tape, neuromuscular block and Surgical rating score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laparoscopic gynecologic surgery
- American Society of Anesthesiologists Physical Status ASA 1-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Neuromuscular Blockade
- Being tested
- measuring tape, neuromuscular block, Surgical rating score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring tapeOther
measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.
neuromuscular blockOther
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 scoreOther
assessment of operating conditions by means of a standardized score: surgical rating score:
- extremely poor conditions
- poor conditions
- acceptable conditions
- good conditions
- optimal conditions
| Study group | Role | What they receive |
|---|---|---|
| abdominal wall length | Other | Measurement of abdominal wall length during neuromuscular block with a measuring tape Receives: Other: measuring tape; Other: neuromuscular block; Other: Surgical rating score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during operation
Secondary outcomes (2)
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
Measured: 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.
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kreiskrankenhaus Dormagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Soltesz, MD, Principal investigator, Kreiskrankenhaus Dormagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605628
- Sponsor's protocol ID
- NMB Abdomen
- Status last verified
- Aug 2022
- First submitted
- 12 Apr 2018
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions During Gynecologic Laparoscopic Operations
- ClinicalTrials.gov ID
- NCT03605628
- Acronym / sponsor ID
- NMB Abdomen
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kreiskrankenhaus DormagenUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal wall length | Other | Other: measuring tape, Other: neuromuscular block, Other: Surgical rating scoreMeasurement of abdominal wall length during neuromuscular block with a measuring tape |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- laparoscopic gynecologic surgery
- American Society of Anesthesiologists Physical Status ASA 1-2
Key exclusion criteria (7 listed)
- anticipated difficult airway
- increased risk for pulmonary aspiration
- acute infection
- pregnancy
- impaired liver- oder kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring tapemeasurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape. | Other | abdominal wall length |
| neuromuscular blockMeasurement 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 | abdominal wall length |
| Surgical rating scoreassessment 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 | Other | abdominal wall length |
Primary outcome
change in abdominal wall length (cm) during time course of the block
Time frame: during operation
Changes in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.
2 secondary outcomes
Change of surgical Rating scale (SRS) scores during neuromuscular block
Time frame: during operation
changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Soltesz, MD principal investigator
Kreiskrankenhaus Dormagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measuring tape, neuromuscular block and Surgical rating score in people with Neuromuscular Blockade, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in abdominal wall length (cm) during time course of the block (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.