The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJanuary 30, 2020
January 1, 2020
7 months
January 23, 2020
January 29, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Study Arms (1)
laparoscopic gastrectomy with pneumoperitoneum
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
- patients who has epidural catheter to manage postoperative pain control
- patients who agree to our study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JIWON LEE, Dr
Dongsan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 30, 2020
Study Start
January 1, 2020
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
January 30, 2020
Record last verified: 2020-01