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Trial record 96 of 695 for:    CARBON DIOXIDE AND arterial

The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

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ClinicalTrials.gov Identifier: NCT04247373
Recruitment Status : Not yet recruiting
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jiwon Lee, Keimyung University Dongsan Medical Center

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date January 30, 2020
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Changes from baseline in heart rate (bpm) after CO2 insufflation [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum
Official Title  ICMJE The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Laparoscopic Gastrectomy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: laparoscopic gastrectomy with pneumoperitoneum
Intervention: Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiwon Lee, Dr +82532587770 belief705@gmail.com
Contact: Hyung-wook Lim 82532506691 irbdsmc@naver.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04247373
Other Study ID Numbers  ICMJE 2018-12-036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiwon Lee, Keimyung University Dongsan Medical Center
Study Sponsor  ICMJE Keimyung University Dongsan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JIWON LEE, Dr Dongsan Medical Center
PRS Account Keimyung University Dongsan Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP