The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Gastrectomy
• Intervention / Treatment: Drug: Ropivacaine

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic gastrectomy with pneumoperitoneum	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: JIWON LEE, Dr, Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2018-12-036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No