The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

Laparoscopic Gastrectomy Clinical Trial

Official title:

The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04247373
• Other study ID #: 2018-12-036
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: Jiwon Lee, Dr
• Phone: +82532587770
• Email: belief705[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients undergoing laparoscopic gastrectomy that require pneumoperitoneum

• patients who has epidural catheter to manage postoperative pain control

• patients who agree to our study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Laparoscopic Gastrectomy
• Pneumoperitoneum

Intervention

Drug:
• Ropivacaine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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