The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

Not Applicable

• Conditions: Laparoscopic Gastrectomy
• Interventions: Drug: Ropivacaine

• Registration Number: NCT04247373
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

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 Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laparoscopic gastrectomy with pneumoperitoneum	Ropivacaine	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline in heart rate (bpm) after CO2 insufflation	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	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.