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Trial record 34 of 693 for:    CARBON DIOXIDE AND arterial

Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients (Oxygenation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721536
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sedat AKBAS, Inonu University

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE October 18, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
The level of partial oxygen pressure [ Time Frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) ]
The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
  • Heart rate [ Time Frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) ]
    Heart rate is measured as beats/minute on the anesthesia monitor
  • Mean arterial pressure [ Time Frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) ]
    Mean arterial pressure is measured as mmHg on the anesthesia monitor
  • Peripheral oxygen saturation [ Time Frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) ]
    Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients
Official Title  ICMJE Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial
Brief Summary Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.
Detailed Description

Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Morbid Obesity
  • Hemodynamic Instability
  • Bariatric Surgery Candidate
Intervention  ICMJE
  • Diagnostic Test: hemodynamic parameters
    vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide
    Other Names:
    • heart rate
    • mean arterial pressure
    • peripheral oxygen saturation
    • End-tidal Carbon Dioxide
  • Diagnostic Test: arterial blood gase
    Arterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control.
    Other Names:
    • partial oxygen pressure
    • partial carbon dioxide pressure
Study Arms  ICMJE
  • Active Comparator: low-flow anesthesia
    Patients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.
    Interventions:
    • Diagnostic Test: hemodynamic parameters
    • Diagnostic Test: arterial blood gase
  • Active Comparator: normal-flow anesthesia
    Patients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.
    Interventions:
    • Diagnostic Test: hemodynamic parameters
    • Diagnostic Test: arterial blood gase
Publications * Nunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
  • Aged 18-65 years old,
  • BMI>40

Exclusion Criteria:

  • Pregnant
  • Uncontrolled diabetes mellitus,
  • Cardiovascular disease,
  • Pulmonary disease,
  • Cerebrovascular disease,
  • Drug and alcohol addiction.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03721536
Other Study ID Numbers  ICMJE sedatakbas4
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Sedat AKBAS, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sedat Akbas, Asst Prof Inonu University Medical Faculty
PRS Account Inonu University
Verification Date January 2019

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