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Low Flow Anesthesia in Morbid Obesity

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ClinicalTrials.gov Identifier: NCT03913858
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Evrim Kucur Tulubas, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary:
In this study to planned to research the efficacy of low-flow anesthesia on patients undergoing sleeve gastrectomy due to morbid obesity on respiratory functions after surgery by examining FEV1 and FVC values and FEV1/FVC ratio.

Condition or disease Intervention/treatment Phase
Morbid Obesity Anesthesia Complication Anesthesia; Functional Procedure: Obesity Surgery with Low-Flow Anesthesia Procedure: Obesity Surgery with High-Flow Anesthesia Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Does Low Flow Anesthesia Protect Lung Functions in Laparoscopic Sleeve Gastrectomy?
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : June 10, 2019
Estimated Study Completion Date : July 10, 2019

Arm Intervention/treatment
high-flow anesthesia
Before beginning induction, first 3 mg midazolam and fentanyl 150 mvq IV were administered. According to ideal weight and BIS score for 40-60, 2-5 mg propofol and 0.5 mg rocuronium according to true weight were administered. After intubation 50 mg ranitidine and 8 mg ondansetron were routinely administered. Fixing the remifentanil dose to 0.1 mcg/kg/min, infusion was administered. Group 1 had 4 liter/minute (50% O2, 50% air) flow administered. Mechanical ventilator settings were 6-10 ml tidal volume, frequency 12/min (increasing, if necessary, for etCO2 35-45 mmHg), PEEP 5-10 cm/H2O and inspirium/expirium ratio ½. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered.
Procedure: Obesity Surgery with High-Flow Anesthesia
Group 2 had 4 liter/minute (50% O2, 50% air) flow administered.
Other Name: Procedure/Anesthesia

low-flow anesthesia
Before beginning induction, first 3 mg midazolam and fentanyl 150 mvq IV were administered. According to ideal weight and BIS score for 40-60, 2-5 mg propofol and 0.5 mg rocuronium according to true weight were administered. After intubation 50 mg ranitidine and 8 mg ondansetron were routinely administered. Fixing the remifentanil dose to 0.1 mcg/kg/min, infusion was administered. Group 2 had 1 liter/minute (50% O2, 50% air) flow administered. Mechanical ventilator settings were 6-10 ml tidal volume, frequency 12/min (increasing, if necessary, for etCO2 35-45 mmHg), PEEP 5-10 cm/H2O and inspirium/expirium ratio ½. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered.
Procedure: Obesity Surgery with Low-Flow Anesthesia
Group 1 had 1 liter/minute (50% O2, 50% air) flow administered.
Other Name: Procedure/Anesthesia




Primary Outcome Measures :
  1. Pulmonary Function Test Results [ Time Frame: Preoperative 1st hour and postoperative 24th hours ]
    FEV1/FVC (%) ratio in hundred morbid obese patients who will undergo laparoscopic sleeve gastrectomy under low flow and high flow anesthesia will be measured


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 72th hours ]
    Length of hospital stay (days) of hundred morbid obese patients who will undergo laparoscopic sleeve gastrectomy under low flow and high flow anesthesia will be measured.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • american Society of Anesthesiologists (ASA) III
  • body mass index (BMI) >40.
  • FEV1/FVC ratio within normal limits
  • FEV1 and FVC values within normal limits
  • those with stop-bang score below 4

Exclusion criteria:

  • alcohol abuse
  • drug abuse
  • previous abdominal surgery.
  • chronic obstructive pulmonary disease (COPD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913858


Contacts
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Contact: Evrim Kucur Tulubas, Dr 00905059360306 evrim.kucurtulubas@saglik.gov.tr
Contact: Kivanc D Peker, Dr 00905325203659 pekerkivancderya@gmail.com

Locations
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Turkey
Bakırköy Dr. Sadi Konuk Trainig And Research Hospital Recruiting
Istanbul, Turkey
Contact: Yasemin Tekdöş Şeker       yasemintekdos@gmail.com   
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
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Principal Investigator: Evrim Kucur Tulubas, Dr

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Responsible Party: Evrim Kucur Tulubas, Department of Anesthesiology and Critical Care Medicine Attending Anaesthesia, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03913858     History of Changes
Other Study ID Numbers: Obesity Surgery FEV1/FVC
Evrim Kucur Tulubas ( Other Identifier: Bakirkoy Dr. Sadi Konuk Training and Research Hospital )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evrim Kucur Tulubas, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
Morbid Obesity
Sleeve Gastrectomy
Low Flow Anesthesia
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs