Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Morbid Obesity |
Drug: Sevoflurane Drug: Propofol- Remifentanyl Drug: Propofol, Remifentanyl |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Propofol Versus Sevoflurane as Sole Anesthetic Agent in Gastric By-Pass Surgery for Morbid Obesity: A Prospective Randomized Clinical Trial |
- Change from baseline of perioperative haemodynamic measurements (HR, MAP), recovery scores (Aldrete, White,Chung) [ Time Frame: 5 min after induction, 1 hour after induction, end of the surgery, 2 hours postoperatively ] [ Designated as safety issue: Yes ]
- Drug Consumption, Drug Cost. [ Time Frame: End of the surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SEVO group
Anaesthesia will be induced with IV Propofol (2 mg/kg TW [TW = ideal body weight, IBW + 0.4 * difference to the excess weight]), Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW).Intraoperatively Sevoflurane will be guided by a target end tidal concentration 1 - 2 MAC .Every rise of BP or HR > 15% of baseline will be followed by a bolus SEVO inhalation 8% MAC for 2 minutes.If the positive sympathetic response persists, then Nifedipine 10 mg will be administered sublingual, if HR < 70/ minute, and Diltiazem 10-20 mg IV will be administered if HR > 70/ minute, followed by esmolol administration if response to diltiazem is unsatisfactory. The duration and frequency of positive sympathetic stress responses that required pharmacologic intervention will be recorded.
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Drug: Sevoflurane
Intraoperatively Sevoflurane will be guided by a target end tidal concentration 1 - 2 MAC .Every rise of BP or HR > 15% of baseline will be followed by a bolus SEVO inhalation 8% MAC for 2 minutes
Other Name: Sevoflurane , Abbott
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Active Comparator: SEVO-BIS group
Anaesthesia will be induced with IV Propofol (2 mg/kg TW [TW = ideal body weight, IBW + 0.4 * difference to the excess weight]), Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW).Intraoperatively Sevoflurane will be guided by a target BIS of 40 - 50 .Every rise of BP or HR > 15% of baseline will be followed by a bolus SEVO inhalation 8% MAC for 2 minutes. If the positive sympathetic response persists, then Nifedipine 10 mg will be administered sublingual, if HR < 70/ minute, and Diltiazem 10-20 mg IV will be administered if HR > 70/ minute, followed by esmolol administration if response to diltiazem is unsatisfactory. The duration and frequency of positive sympathetic stress responses that required pharmacologic intervention will be recorded.
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Drug: Sevoflurane
Intraoperatively sevoflurane will be guided by a target BIS of 40 - 50. If a positive sympathetic response occured (an elevation of the HR and/or MAP greater than 15% above baseline) a bolus SEVO 8 MAC will be administered for 2 minutes.
Other Name: Sevoflurane, Abbott and BIS, Aspect Medical Systems, USA
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Active Comparator: Propo- Remi group
General Anaesthesia (GA) will be induced with a continuous IV Propofol (P) infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (R, 1 μg/kg IBW) and succinylcholine (1mg/kg IBW). GA will be maintained with continuous intravenous administration of P at 150-300mcg/kg/min (doses based on ideal body weight). Every rise of BP or HR > 15% of baseline will be followed by a R bolus IV (1 μg/kg IBW) and increase in the continuous infusion rate of R to 1.0 μg/kg/min . If HR < 70/ minute, and Diltiazem 10-20 mg IV will be administered if HR > 70/ minute, followed by esmolol administration if response to diltiazem is unsatisfactory. The duration and frequency of stress responses that required intervention is recorded. |
Drug: Propofol- Remifentanyl
Anaesthesia will be induced with a continuous IV Propofol infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW).General anesthesia will be maintained with continuous intravenous administration of Propofol at 150-300mcg/kg/min (doses based on ideal body weight). Every rise of BP or HR > 15% of baseline will be followed by a Remifentanyl bolus IV (1 μg/kg IBW) and increase in the continuous infusion rate of Remifentanyl from 0.1 to 1.0 μg/kg/min Other Names:
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Active Comparator: Propo-Remi-BIS group
General Anaesthesia (GA) will be induced with a continuous IV Propofol (P) infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (R, 1 μg/kg IBW) and succinylcholine (1mg/kg IBW). GA will be maintained with continuous intravenous administration of P at 150-300mcg/kg/min (IBW). The depth of anesthesia will be adjusted to accomplish a BIS score 40 -50. If BP or HR is > 15% of baseline will a bolus of R IV (1 μg/kg IBW) will be given and an the infusion rate of R will be increased to 1.0 μg/kg/min . If this response persists and HR < 70/ min, Nifedipine 10 mg will be given s.l. and if HR > 70/ min Diltiazem 10-20 mg IV will be given, followed by esmolol infusion if no response is observed. |
Drug: Propofol, Remifentanyl
Anaesthesia will be induced with a continuous IV Propofol infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW). General anesthesia will be maintained with continuous intravenous administration of Propofol at 150-300mcg/kg/min (ideal body weight). The depth of anesthesia will be adjusted so as to accomplish a BIS score between 40 and 50 Every rise of BP or HR > 15% of baseline will be followed by a 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 Other Name: Propofol, Fresenius, BIS, Aspect Medical Systems, USA
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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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kriton Filos, Professor,MD, PhD | 00302610999341 | kritonfilos@yahoo.gr |
| Contact: Athina Siampalioti, MD | 6944678681 | atenaba@in.gr |
| Greece | |
| University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine | Recruiting |
| Patras, Achaia, Greece, 26500 | |
| Contact: Kriton Filos, Professor 00302610999341 kritonfilos@yahoo.gr | |
| Principal Investigator: | Athina Siampalioth, MD | University of Patras, Departement of Anesthesiology and Critical Care Medicine |
| Study Chair: | Kriton Filos, Professor, MD, PhD | University of Patras, Departement of Anesthesiology and Critical Care Medicine |
More Information
No publications provided
| Responsible Party: | Kriton Filos, University of Patras, Departement of Anesthesiology and Critical Care Medicine |
| ClinicalTrials.gov Identifier: | NCT01279499 History of Changes |
| Other Study ID Numbers: | sevoflurane-propofol-obesity |
| Study First Received: | January 11, 2011 |
| Last Updated: | January 19, 2011 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Patras:
|
Morbid obesity Sevoflurane Propofol Remifentanyl |
BIS Cardiovascular stability Recovery scores Drug consumption |
Additional relevant MeSH terms:
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Obesity, Morbid Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Anesthetics Propofol Sevoflurane Remifentanil Succinylcholine Anesthetics, Intravenous Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuromuscular Depolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Anesthetics, General Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Analgesics, Opioid Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013