Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Patras.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01279499
First received: January 11, 2011
Last updated: January 19, 2011
Last verified: March 2010
  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
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

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.
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
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.
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
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:
  • Propofol, Diprivan, Fresenius
  • Remifentanyl, Ultiva, GlaxoSmithKline
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

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279499

Contacts
Contact: Kriton Filos, Professor,MD, PhD 00302610999341 kritonfilos@yahoo.gr
Contact: Athina Siampalioti, MD 6944678681 atenaba@in.gr

Locations
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   
Sponsors and Collaborators
University of Patras
Investigators
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:
Obesity
Obesity, Morbid
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
Hypnotics and Sedatives
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Narcotics
Analgesics

ClinicalTrials.gov processed this record on August 28, 2014