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Trial record 77 of 667 for:    CARBON DIOXIDE AND arterial

Anesthetics and Cerebral Oxygenation in LSG

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ClinicalTrials.gov Identifier: NCT03946657
Recruitment Status : Active, not recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cengiz KAYA, Ondokuz Mayıs University

Brief Summary:

Obesity is a global health issue that affects different organ systems and may cause severe health issues. Patients with a BMI > 40 kg/m2 or those with a BMI > 35 kg/m2 with accompanying comorbidities are candidates for weight loss surgeries, which are generally referred to as bariatric surgeries. Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgery procedure gaining increased popularity in the surgical treatment of morbid obesity. However, LSG requires a reverse-Trendelenburg position and prolonged pneumoperitoneum. Carbon dioxide pneumoperitoneum increases intracranial pressure (ICP) by increasing intra-abdominal pressure and by causing dilation of cerebral vessels through carbon dioxide reabsorption. Also, the reverse-Trendelenburg position decreases cardiac output and mean arterial pressure (MAP) by reducing cardiac venous return. A Near-infrared spectroscopy (NIRS) is a non-invasive technique and provides continuous monitoring of regional cerebral tissue oxygen saturation (rSO2).

Sevoflurane and propofol are widely used for the maintenance of general anesthesia during bariatric surgery. Sevoflurane is an efficacious halogenated inhalational anesthetic for bariatric surgery because of its rapid and consistent recovery and because it does not cause hemodynamic instability because of its low blood solubility. Moreover, it increases global CBF through a direct intrinsic cerebral vasodilatory action and, in addition, it might improve cerebral oxygenation by decreasing the cerebral metabolic rate of oxygen (CMRO2) (luxury perfusion). Propofol can also be a suitable option for the maintenance of anesthesia in bariatric surgery. Propofol is a short-acting intravenous anesthetic agent with a very good recovery profile, and its elimination half-life and duration of action do not change in obese individuals. However, it has been reported that propofol may significantly decrease CBF by both suppressing CMRO2 and through a direct vasoconstrictive action. The impact of propofol on global CBF is more salient than that on CMRO2, resulting in a decrease in rSO2. The aim of the present study was to test the hypothesis that rSO2 is better preserved with sevoflurane than propofol in morbidly obese patients who have undergone LSG.


Condition or disease Intervention/treatment Phase
Morbid Obesity Bariatric Surgery Candidate Anesthesia Drug: Inhalational anesthetic Drug: Intravenous anesthetic Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For the investigation, the patients were randomly assigned to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). The anesthesiologist caring for the patient was aware of the group assignments. The patients were blinded to the group assignments.
Masking: Single (Participant)
Masking Description: The patients were randomly assigned using opaque sealed envelopes to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). Randomization was performed according to a computer-generated randomization code, and a statement showing the patients' group was placed in sealed, numbered enveloped according to the results. Each patient drew an envelope and was enrolled in the study depending on the group written in the envelope. Randomization was performed by a physician who was not involved in the monitorization of the patients.
Primary Purpose: Supportive Care
Official Title: A Comparison of Cerebral Oximetry After Propofol-Based Total Intravenous Anesthesia and Sevoflurane Inhalation Anesthesia in Morbidly Obese Patients Undergoing LSG: a Prospective, Single-Blinded, Randomized, Parallel-Group Study.
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

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Arm Intervention/treatment
Active Comparator: The Inhalation Group
Sevoflurane (1 minimum alveolar concentration [MAC]) were used in the Inhalation group for the maintenance of anesthesia.
Drug: Inhalational anesthetic
Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.

Active Comparator: The TIVA (total intravenous anesthesia) Group
Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.
Drug: Intravenous anesthetic
Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.




Primary Outcome Measures :
  1. Cerebral oxygen saturation [ Time Frame: The rSO2 values of the patients were recorded from baseline untill 20 minutes after the extubation, up to 120 min. ]
    The rSO2 values of the patients were recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. Measurements in the last 30 seconds of preoxygenation, performed for three minutes with 4 L/min oxygen (80%) pre-induction, were accepted as preoperative values.Cerebral oxygen desaturation was defined as a greater than 25% decrease in the rSO2 value compared to the preoperative value (decrease should be more than 20% if the preoperative value is <50) and maintenance of this situation for ≥15 seconds. In this case, the following algorithm was used. First of all, normotension of the patient was ensured (administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and the patient's neck was checked. External factors causing arterial or venous obstruction were restored, if any. If no recovery was seen despite these steps, FiO2 was set at 100%.

  2. Arterial Blood Gas (ABG) analysis-pH [ Time Frame: The pH values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The pH values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.

  3. Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide [ Time Frame: The partial pressure of carbon dioxide values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The partial pressure of carbon dioxide values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.

  4. Arterial Blood Gas (ABG) analysis-Hemoglobin [ Time Frame: The hemoglobin values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The hemoglobin values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.


Secondary Outcome Measures :
  1. The heart rate (HR) measurement [ Time Frame: The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The heart rate was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. HR values were allowed to fluctuate up to 20% of the preoperative values of the patients. For this purpose, the infusion rate of remifentanil was accordingly increased and decreased. Whenbradycardia (HR <45 beats/minute) continued for longer than three minutes, they were treated with IV 0.5 mg atropine.

  2. The oxygen saturation measurement [ Time Frame: The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The oxygen saturation was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  3. The mean arterial pressure measurement [ Time Frame: The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  4. The end-tidal carbon dioxide partial pressure measurement [ Time Frame: The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The end-tidal carbon dioxide partial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  5. The anesthesia time (min) [ Time Frame: The anesthesia time was recorded through study completion. ]
    The anesthesia time was defined as the length of time the patient was anesthetized.

  6. The reverse-Trendelenburg time (min) [ Time Frame: The reverse-Trendelenburg time was recorded through study completion. ]
    The reverse-Trendelenburg time was defined as the length of time the patient was in the reverse-Trendelenburg position.

  7. The pneumoperitoneum time (min) [ Time Frame: The pneumoperitoneum time was recorded through study completion. ]
    The pneumoperitoneum time was defined as the length of time the patient had pneumoperitoneum

  8. The recovery time (min) [ Time Frame: The recovery time was recorded at the end of the surgery untill the extubation. ]
    The recovery time was defined as the time from discontinuation of sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of the observer and extubation.



Information from the National Library of Medicine

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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:

  • The American Society of Anaesthesiologists (ASA) physical status class II-III
  • BMI of ≥ 35 kg/m2
  • Patients were planning on undergoing an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

  • Patients with preexisting cerebrovascular diseases, overt neurological signs, alcohol or psychoactive drug addiction
  • Uncontrolled diabetes or hypertension
  • Advanced organ failure
  • Preoperative peripheral oxygen saturation (SpO2) less than 96%
  • Hemoglobin <9 g/dL .

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): NCT03946657


Locations
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Turkey
Ondokuz Mayis Universitesi
Samsun, Atakum, Turkey, 55139
Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
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Principal Investigator: CENGIZ KAYA, Assoc. Prof. Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

Publications:
Schofield DL, Morton PG, Brokos C, Gruel R, Johannes S, McBride N, et al. Perioperative Assessment and Risk Stratification of the Obese Patient. Bariat Nurs Surg Pat 2011;6:201 - 206.
Yorulmaz IS, Demiraran Y, Salihoglu Z, Umutoglu T, Ozaydin I, Dogan S. Effect of PEEP, Zero PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation in the Morbidly Obese Undergoing Sleeve Gastrectomy. Bariatr Surg Pract P 2017;12:123 - 129.
Honca M, Honca T. Comparison of Propofol with Desflurane for Laparoscopic Sleeve Gastrectomy in Morbidly Obese patients: A Prospective Randomized Trial. Bariatr Surg Pract P 2017;12:49 - 54.

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Responsible Party: Cengiz KAYA, Associate Professor, MD, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT03946657     History of Changes
Other Study ID Numbers: B.30.2.ODM.0.20.08/27-230
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Cengiz KAYA, Ondokuz Mayıs University:
Bariatric
Surgery
Sevoflurane
Propofol
Oximetry
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation