Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients
Information source: University of Patras
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Morbid Obesity
Intervention: Sevoflurane (Drug); Sevoflurane (Drug); Propofol- Remifentanyl (Drug); Propofol, Remifentanyl (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Patras Official(s) and/or principal investigator(s): Athina Siampalioth, MD, Principal Investigator, Affiliation: University of Patras, Departement of Anesthesiology and Critical Care Medicine Kriton Filos, Professor, MD, PhD, Study Chair, Affiliation: University of Patras, Departement of Anesthesiology and Critical Care Medicine
Overall contact: Kriton Filos, Professor,MD, PhD, Phone: 00302610999341, Email: kritonfilos@yahoo.gr
Summary
The objective of this prospective randomized clinical study was to compare anesthesia, in
morbidly obese patents (BMI >50) who underwent BPD-RYGBP with either sevoflurane or propofol
with remifentanyl.
Clinical Details
Official title: Propofol Versus Sevoflurane as Sole Anesthetic Agent in Gastric By-Pass Surgery for Morbid Obesity: A Prospective Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline of perioperative haemodynamic measurements (HR, MAP), recovery scores (Aldrete, White,Chung)
Secondary outcome: Drug Consumption, Drug Cost.
Detailed description:
This is a prospective double blind randomized controlled trial. The patients will be
assigned to one of 4 groups (gr): (1) SEVO group, guided by a target end tidal concentration
1 - 2 MAC and modified according to the haemodynamics (BP, HR) of the patients using a bolus
inhalation (4 MAC), (2) SEVO-BIS group, using SEVO to a target BIS of 40 - 50, (3)
PROPO-REMI and (4) PROPO-REMI-BIS groups accordingly. In groups 1 and 2, anaesthesia will
be induced with IV PROPO (2 mg/kg TW [TW = ideal body weight, IBW + 0. 4 * difference to the
excess weight]), REMI (1 μg/kg IBW) and succinylcholine (1mg/kg IBW). In groups 3, 4
anaesthesia will be induced with a continuous IV PROPO infusion (21mg/kg TW/h for 5 min, 12
mg/kg TW/h for 10 min and then 6 mg/kg TW/h), followed by an IV bolus of REMI and
succinylcholine as above. Every rise of BP or HR > 15% of baseline will be followed by a
bolus SEVO inhalation in grs 1 and 2 or REMI bolus IV (1 μg/kg IBW) and increase in the
continuous infusion rate of REMI from 0. 1 to 1. 0 μg/kg/min in groups 3 and 4. An epidural
catheter will be placed prior to induction for postoperative analgesia only. Intraoperative
BP and HR, anaesthetic consumption, recovery scores (Aldrete, Chung, White) and anaesthesia
cost will be evaluated.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-50 yrs
- BMI>50 kg/m2
- Written consent for the participation in the study
Exclusion Criteria:
- History of significant cardiac disease, (aortic stenosis, angina, CHF or previous
cardiac or intrathoracic operations)
- Significant renal dysfunction (serum creatinine>1. 8 mg/dl)
- Significant liver dysfunction (evidenced by abnormal LFTs)
- History of hyper or hypothyroidism
- History of psychiatric or neurologic disorders
- Recall during general anesthesia
- Substance abuse (alcohol or other drugs)
- Counter-indications of placement of thoracic epidural catheter( previous spine
surgery or coagulation abnormalities )
- Refusal to participate in the study
Locations and Contacts
Kriton Filos, Professor,MD, PhD, Phone: 00302610999341, Email: kritonfilos@yahoo.gr
University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine, Patras, Achaia 26500, Greece; Recruiting Kriton Filos, Professor, Phone: 00302610999341, Email: kritonfilos@yahoo.gr
Additional Information
Starting date: April 2010
Last updated: January 19, 2011
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