- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946657
Anesthetics and Cerebral Oxygenation in LSG
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients were administered 300 mg of oral ranitidine the night before the surgery and 10 mg intravenous (IV) metoclopramide in combination with 150 mg ranitidine one hour before arrival to the operating room. Upon the arrival to the operating room, an electrocardiogram, noninvasive blood pressure, SpO2, rSO2 (INVOSTM 5100C oximeter; Covidien, Massachusetts, USA) and neuromuscular monitorization (TOF-WatchTM SX, Organon, Dublin, Ireland) were performed on the patients. Afterwards, preoxygenation was performed with 4 L/min oxygen (80%) for three minutes by using facemasks, and anesthesia was induced with an IV propofol injection (1.5-2.5 mg/kg of ideal body weight) and an IV bolus administration of remifentanil [1 mcg/kg of lean body weight (LBW)] for 30-60 s, and then switched to infusion at 0.25 mcg/kg of LBW/min. After the eyelid reflex disappeared, a neuromuscular blockade was performed using rocuronium (1.2 mg/kg of LBW), ensuring that the train-of-four count and the post-tetanic count (PTC) were both zero, and performed tracheal intubation. Mechanical ventilation was performed with a Draeger FabiusTM Plus anesthesia workstation (Draeger Medical, Lübeck, Germany), and volume-controlled mechanical ventilation was applied. Breathing gases (oxygen, carbon dioxide, sevoflurane) were measured using Draeger ScioTM gas measurement module (Draeger Medical, Lübeck, Germany). The tidal volume was set as 7-8 mL/kg of LBW, inspiratory: expiratory ratio as 1:2, positive end-expiratory pressure as 5-8 cmH2O, and the respiratory rate was determined to obtain an end-tidal carbon dioxide partial pressure (PETCO2) of 32-37 mmHg. These ventilator settings were not changed throughout the operation. Furthermore, after the induction of anesthesia, a radial arterial line was placed in all patients for the continuous measurement of mean arterial pressure and intermittent arterial blood gas analysis.
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 in the Inhalation group for the maintenance of anesthesia. 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 in the TIVA group. Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero. IV normal saline or lactated Ringer's solution at 5-7 mL/kg of LBW was also used for perioperative fluid maintenance. Nasopharyngeal temperature was monitored throughout the surgery, and the patient temperature (36-37°C) was ensured by using a forced-air warming system for the maintenance of intraoperative normothermia during the procedure.
After anesthesia induction, a neutral head position of the patients was preserved to prevent alteration of cerebral venous drainage. Carbon dioxide insufflation was performed with an electronic laparoflator using a closed Veress needle technique, and intra-abdominal pressure was automatically kept at the desired level (14-16 mmHg) during the surgery. After the insufflation of carbon dioxide, the patients were positioned in a 30° reverse-Trendelenburg and at a 10° right lateral position.
At the end of the surgery, the blockade was reversed by administering 4 mg/kg of adjusted body weight sugammadex with a PTC of 1-2. All patients were extubated in the beach chair position when fully awake. The patients were referred to the recovery unit and monitored for 50 minutes for complications. In cases where no complications were apparent, the recovery was evaluated using the modified Aldrete scoring system. Once the score was ≥9, the patients were taken to unit. For postoperative nausea and vomiting, 4-5 mg dexamethasone was used (except for diabetic patients on insulin) 90 min before anesthesia induction and 4-8 mg IV ondansetron 20-30 min before the end of the operation. For postoperative pain management, 1 g IV acetaminophen was administered 20 min after induction and 30 mg IV ketorolac 20 min before onset. Then, 1 g IV acetaminophen was administered every 6 h + 50 mg IV dexketoprofen every 8 h for the first 48 hours. In addition, morphine was administered using a patient-controlled analgesia delivery system (demand dose, 20 µg/kg of ideal body weight; lockout time, 6-10 min; 4 h limit, 80% of the total calculated dosage) for 48 h postoperatively.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Atakum
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Samsun, Atakum, Turkey, 55139
- Ondokuz Mayis Universitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
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
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.
|
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
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min.
|
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.
|
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
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.
|
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
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.
|
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)
Time Frame: The anesthesia time was recorded through study completion.
|
The anesthesia time was defined as the length of time the patient was anesthetized.
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The anesthesia time was recorded through study completion.
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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.
|
The reverse-Trendelenburg time was recorded through study completion.
|
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
|
The pneumoperitoneum time was recorded through study completion.
|
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.
|
The recovery time was recorded at the end of the surgery untill the extubation.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CENGIZ KAYA, Assoc. Prof., Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dagal A, Lam AM. Cerebral autoregulation and anesthesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):547-52. doi: 10.1097/ACO.0b013e32833020be.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ODM.0.20.08/27-230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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