Anesthetics and Cerebral Oxygenation in LSG

NCT03946657 | Completed Phase 4

• 1 other identifier: B.30.2.ODM.0.20.08/27-230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Bariatric Surgery Candidate; Anesthesia

Keywords

Bariatric; Surgery; Sevoflurane; Propofol; Oximetry

Outcome Measures

Primary Outcomes (4)

• Cerebral oxygen saturation

  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%.

  The rSO2 values of the patients were recorded from baseline untill 20 minutes after the extubation, up to 120 min.

• Arterial Blood Gas (ABG) analysis-pH

  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.

  The pH values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min.

• Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide

  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.

  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.

• Arterial Blood Gas (ABG) analysis-Hemoglobin

  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.

  The hemoglobin values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min.

Secondary Outcomes (8)

• The heart rate (HR) measurement

  The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min.

• The oxygen saturation measurement

  The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 120 min.

• The mean arterial pressure measurement

  The mean arterial 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 measurement

  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 anesthesia time (min)

  The anesthesia time was recorded through study completion.

Study Arms (2)

The Inhalation Group

ACTIVE COMPARATOR

Sevoflurane (1 minimum alveolar concentration \[MAC\]) were used in the Inhalation group for the maintenance of anesthesia.

Drug: Inhalational anesthetic

The TIVA (total intravenous anesthesia) Group

ACTIVE COMPARATOR

Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.

Drug: Intravenous anesthetic

Interventions

Inhalational anesthetic DRUG

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.

The Inhalation Group

Intravenous anesthetic DRUG

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.

The TIVA (total intravenous anesthesia) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (18)

• Soleimanpour H, Safari S, Sanaie S, Nazari M, Alavian SM. Anesthetic Considerations in Patients Undergoing Bariatric Surgery: A Review Article. Anesth Pain Med. 2017 Jul 11;7(4):e57568. doi: 10.5812/aapm.57568. eCollection 2017 Aug.

  PMID: 29430407 BACKGROUND

• 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.

  BACKGROUND

• Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010 Aug;252(2):319-24. doi: 10.1097/SLA.0b013e3181e90b31.

  PMID: 20622654 BACKGROUND

• 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.

  BACKGROUND

• Willeumier KC, Taylor DV, Amen DG. Elevated BMI is associated with decreased blood flow in the prefrontal cortex using SPECT imaging in healthy adults. Obesity (Silver Spring). 2011 May;19(5):1095-7. doi: 10.1038/oby.2011.16. Epub 2011 Feb 10.

  PMID: 21311507 BACKGROUND

• Sollazzi L, Perilli V, Modesti C, Annetta MG, Ranieri R, Tacchino RM, Proietti R. Volatile anesthesia in bariatric surgery. Obes Surg. 2001 Oct;11(5):623-6. doi: 10.1381/09608920160557138.

  PMID: 11594107 BACKGROUND

• Kaisti KK, Langsjo JW, Aalto S, Oikonen V, Sipila H, Teras M, Hinkka S, Metsahonkala L, Scheinin H. Effects of sevoflurane, propofol, and adjunct nitrous oxide on regional cerebral blood flow, oxygen consumption, and blood volume in humans. Anesthesiology. 2003 Sep;99(3):603-13. doi: 10.1097/00000542-200309000-00015.

  PMID: 12960544 BACKGROUND

• Servin F, Farinotti R, Haberer JP, Desmonts JM. Propofol infusion for maintenance of anesthesia in morbidly obese patients receiving nitrous oxide. A clinical and pharmacokinetic study. Anesthesiology. 1993 Apr;78(4):657-65. doi: 10.1097/00000542-199304000-00008.

  PMID: 8466066 BACKGROUND

• Engelhard K, Werner C. Inhalational or intravenous anesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006 Oct;19(5):504-8. doi: 10.1097/01.aco.0000245275.76916.87.

  PMID: 16960482 BACKGROUND

• 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.

  BACKGROUND

• Reinsfelt B, Westerlind A, Ricksten SE. The effects of sevoflurane on cerebral blood flow autoregulation and flow-metabolism coupling during cardiopulmonary bypass. Acta Anaesthesiol Scand. 2011 Jan;55(1):118-23. doi: 10.1111/j.1399-6576.2010.02324.x. Epub 2010 Oct 7.

  PMID: 21039354 BACKGROUND

• Dagal A, Lam AM. Cerebral autoregulation and anesthesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):547-52. doi: 10.1097/ACO.0b013e32833020be.

  PMID: 19620861 BACKGROUND

• Klein KU, Schramm P, Glaser M, Reisch R, Tresch A, Werner C, Engelhard K. Intraoperative monitoring of cerebral microcirculation and oxygenation--a feasibility study using a novel photo-spectrometric laser-Doppler flowmetry. J Neurosurg Anesthesiol. 2010 Jan;22(1):38-45. doi: 10.1097/ANA.0b013e3181bea439.

  PMID: 19816204 BACKGROUND

• Klein KU, Fukui K, Schramm P, Stadie A, Fischer G, Werner C, Oertel J, Engelhard K. Human cerebral microcirculation and oxygen saturation during propofol-induced reduction of bispectral index. Br J Anaesth. 2011 Nov;107(5):735-41. doi: 10.1093/bja/aer227. Epub 2011 Jul 31.

  PMID: 21862494 BACKGROUND

• Jeong H, Jeong S, Lim HJ, Lee J, Yoo KY. Cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during arthroscopic shoulder surgery in beach chair position under sevoflurane-nitrous oxide or propofol-remifentanil anesthesia. Anesthesiology. 2012 May;116(5):1047-56. doi: 10.1097/ALN.0b013e31825154d2.

  PMID: 22421420 BACKGROUND

• Valencia L, Rodriguez-Perez A, Kuhlmorgen B, Santana RY. Does sevoflurane preserve regional cerebral oxygen saturation measured by near-infrared spectroscopy better than propofol? Ann Fr Anesth Reanim. 2014 Apr;33(4):e59-65. doi: 10.1016/j.annfar.2013.12.020. Epub 2014 Feb 24.

  PMID: 24582111 BACKGROUND

• Ruzman T, Simurina T, Gulam D, Ruzman N, Miskulin M. Sevoflurane preserves regional cerebral oxygen saturation better than propofol: Randomized controlled trial. J Clin Anesth. 2017 Feb;36:110-117. doi: 10.1016/j.jclinane.2016.10.010. Epub 2016 Dec 1.

  PMID: 28183546 BACKGROUND

• Sen P, Izdes S, But A. Effects of sevoflurane and propofol anaesthesia on cerebral oxygenation during normocapnia and mild hypercapnia: a pilot study. Br J Anaesth. 2013 Feb;110(2):318-9. doi: 10.1093/bja/aes489. No abstract available.

  PMID: 23319678 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Anesthetics, Intravenous

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• CENGIZ KAYA, Assoc. Prof.

  Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: January 20, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)