Laparoscopic GastrectomyNCT04247373
The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum
A study testing Ropivacaine in people with Laparoscopic Gastrectomy, run by Keimyung University Dongsan Medical Center.
Trial summary
Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopic Gastrectomy
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Aug 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
- patients who has epidural catheter to manage postoperative pain control
- patients who agree to our study
Who cannot join
- patients who don't agree to our study
- BMI<16.0 or BMI>35
- cardiovascular disease, pulmonary disease, renal disease
- alcoholic abuser or drug abuser
- any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.
Read the detailed description
According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method.
Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.
- Conditions
- Laparoscopic Gastrectomy
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine the investigators use biased coin design up-and-down method.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic gastrectomy with pneumoperitoneum | Experimental | Not described Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in heart rate (bpm) after CO2 insufflation
Heart rate will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of heart rate before anesthesia induction will be regarded as the baseline values. If maximum heart rate after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
Measured: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Changes from baseline in mean arterial pressure (mmHg) after CO2
Mean arterial pressure will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of mean arterial pressure before anesthesia induction will be regarded as the baseline values. If maximum mean arterial pressure after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
Measured: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic GastrectomyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon Lee, Keimyung University Dongsan Medical Center
- Investigators
- JIWON LEE, Dr, Principal investigator, Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247373
- Sponsor's protocol ID
- 2018-12-036
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT04247373
- Acronym / sponsor ID
- 2018-12-036
- Conditions
- Laparoscopic Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Jan 2020 (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.
Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.
Detailed description
According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method.
Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic gastrectomy with pneumoperitoneum | Experimental | Drug: Ropivacaine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
- patients who has epidural catheter to manage postoperative pain control
- patients who agree to our study
Key exclusion criteria (5 listed)
- patients who don't agree to our study
- BMI<16.0 or BMI>35
- cardiovascular disease, pulmonary disease, renal disease
- alcoholic abuser or drug abuser
- any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
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 |
|---|---|---|
| RopivacaineAccording to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine the investigators use biased coin design up-and-down method. | Drug | laparoscopic gastrectomy with pneumoperitoneum |
Primary outcome
Changes from baseline in heart rate (bpm) after CO2 insufflation
Time frame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Heart rate will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of heart rate before anesthesia induction will be regarded as the baseline values. If maximum heart rate after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
Changes from baseline in mean arterial pressure (mmHg) after CO2
Time frame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Mean arterial pressure will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of mean arterial pressure before anesthesia induction will be regarded as the baseline values. If maximum mean arterial pressure after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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.
JIWON LEE, Dr principal investigator
Dongsan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Laparoscopic Gastrectomy, run by Keimyung University Dongsan Medical Center.
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 5 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jiwon Lee, Dr (+82532587770, belief705@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in heart rate (bpm) after CO2 insufflation (time frame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation). The study lists 2 primary outcomes in all. 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 30 Jan 2020.