AnesthesiaNCT04165057
Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy
A study testing Optimal muscle tension management in people with Anesthesia, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Optimal muscle tension management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20~80 years old
- ASA score : 1-2
- Regular laparoscopic cholecystectomy
Who cannot join
- Renal function impairement (eGFR < 60 ml/min/1.73m2) or ESRD
- BMI < 18.5 kg/m2 or >30 kg/m2
- History of other abdominal surgery
- Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
- Emergent surgery
- Convert to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, 300
YI-PING WANG, MD, +886-3-5326151 ext. 3900, joesph0502@gmail.com
About this study
Official title: Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study
Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.
Read the detailed description
This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.
- Conditions
- Anesthesia
- Being tested
- Optimal muscle tension management
- Keywords
- Laparoscopic surgery, Optimal muscle tension, Neuromuscular monitoring, Neuromuscular blockade, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal muscle tension managementOther
including TOF monitor and reversal of neuromuscular blockade agent : sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Group OMT | Active comparator | Optimal muscle tension management Receives: Other: Optimal muscle tension management |
| Group Control | No intervention | Conventional anesthetic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical condition
Surgeon describe CO2 inflation condition by 4 point King Score (1-4).
- excellent
- good
- acceptable
- poor or unacceptable
Measured: 5 minutes
Secondary outcomes (7)
Peak inspiratory pressure during surgery
Peak inspiratory pressure during surgery
Measured: 1 hour
Mean blood pressure
Mean blood pressure during the CO2 inflation
Measured: Every 5 mins
Total surgical time
Total surgical time
Measured: 1 hour
Total Rocuronium doses during surgery
Total Rocuronium doses during surgery
Measured: 1 hour
Pain score at Postoperative room
describe by 11 points Numeric rating scales (0-10). From 0 which means "no pain" to 10 means "worst pain"
Measured: 1 hour
Heart Rate
Every beat per minutes heart rate during CO2 inflation
Measured: every 5 mins
Respiratory complications
Record any respiratory complications including desaturations (<95%, more than 30 seconds, Rispiratory rate < 8), aspiration or airway obstruction
Measured: Every 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MING-HUI HUNG, MD, Study director, National Taiwan University Hospital Hsinchu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165057
- Sponsor's protocol ID
- 108-084-F
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT04165057
- Acronym / sponsor ID
- 108-084-F
- Conditions
- Anesthesia
- Keywords
- Laparoscopic surgery, Optimal muscle tension, Neuromuscular monitoring, Neuromuscular blockade, Sugammadex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Nov 2019 (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.
Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.
Detailed description
This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group OMT | Active comparator | Other: Optimal muscle tension managementOptimal muscle tension management |
| Group Control | No intervention | –Conventional anesthetic management |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 20~80 years old
- ASA score : 1-2
- Regular laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Renal function impairement (eGFR < 60 ml/min/1.73m2) or ESRD
- BMI < 18.5 kg/m2 or >30 kg/m2
- History of other abdominal surgery
- Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
- Emergent surgery
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 |
|---|---|---|
| Optimal muscle tension managementincluding TOF monitor and reversal of neuromuscular blockade agent : sugammadex | Other | Group OMT |
Primary outcome
Surgical condition
Time frame: 5 minutes
Surgeon describe CO2 inflation condition by 4 point King Score (1-4). 1. excellent 2. good 3. acceptable 4. poor or unacceptable
7 secondary outcomes
Peak inspiratory pressure during surgery
Time frame: 1 hour
Mean blood pressure
Time frame: Every 5 mins
Total surgical time
Time frame: 1 hour
Total Rocuronium doses during surgery
Time frame: 1 hour
Pain score at Postoperative room
Time frame: 1 hour
Heart Rate
Time frame: every 5 mins
Respiratory complications
Time frame: Every 5 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: No
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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.
MING-HUI HUNG, MD study director
National Taiwan University Hospital Hsinchu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal muscle tension management in people with Anesthesia, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI-PING WANG, MD (+886-3-5326151 ext. 3900, joesph0502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical condition (time frame: 5 minutes). 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 15 Nov 2019.