The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

NCT ID: NCT04247373

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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Laparoscopic Gastrectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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laparoscopic gastrectomy with pneumoperitoneum

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jiwon Lee

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIWON LEE, Dr

Role: PRINCIPAL_INVESTIGATOR

Dongsan Medical Center

Central Contacts

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Jiwon Lee, Dr

Role: CONTACT

+82532587770

Hyung-wook Lim

Role: CONTACT

82532506691

Other Identifiers

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2018-12-036

Identifier Type: -

Identifier Source: org_study_id

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