CClinicalTrials.gg
Status unknownNCT04247373Updated Jan 30, 2020

The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

An interventional study of Ropivacaine in Laparoscopic Gastrectomy, sponsored by Keimyung University Dongsan Medical Center. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.

Read the 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%.

02

Conditions studied

  • Laparoscopic Gastrectomy

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03

In context

Pneumoperitoneum

149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.

This study's planned enrollment of 50 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.

Browse Pneumoperitoneum studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    laparoscopic gastrectomy with pneumoperitoneum

    Drug: Ropivacaine

Interventions

  • DrugRopivacaine

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation

  2. 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.

    Time frame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04247373
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Jiwon Lee (assistant professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Jan 30, 2020
Start date
Jan 2020 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Jan 30, 2020

Study contacts

Jiwon Lee, Dr
Contact
belief705@gmail.com
+82532587770
Hyung-wook Lim
Contact
irbdsmc@naver.com
82532506691
JIWON LEE, Dr
principal investigator · Dongsan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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