Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

NCT01279499 | Unknown Phase 2

• 1 other identifier: sevoflurane-propofol-obesity
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity

Keywords

Morbid obesity; Sevoflurane; Propofol; Remifentanyl; BIS; Cardiovascular stability; Recovery scores; Drug consumption

Outcome Measures

Primary Outcomes (1)

• Change from baseline of perioperative haemodynamic measurements (HR, MAP), recovery scores (Aldrete, White,Chung)

  5 min after induction, 1 hour after induction, end of the surgery, 2 hours postoperatively

Secondary Outcomes (1)

• Drug Consumption, Drug Cost.

  End of the surgery

Study Arms (4)

SEVO group

ACTIVE COMPARATOR

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

SEVO-BIS group

ACTIVE COMPARATOR

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

Propo- Remi group

ACTIVE COMPARATOR

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

Propo-Remi-BIS group

ACTIVE COMPARATOR

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

Interventions

Sevoflurane DRUG

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

Also known as: Sevoflurane , Abbott

SEVO group

Propofol, Remifentanyl DRUG

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

Also known as: Propofol, Fresenius, BIS, Aspect Medical Systems, USA

Propo-Remi-BIS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 yrs
• BMI\>50 kg/m2
• Written consent for the participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine

Pátrai, Achaia, 26500, Greece

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Sevoflurane; Propofol; Remifentanil; halofantrine

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)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Athina Siampalioth, MD

  University of Patras, Departement of Anesthesiology and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

• Kriton Filos, Professor, MD, PhD

  University of Patras, Departement of Anesthesiology and Critical Care Medicine

  STUDY CHAIR

Central Study Contacts

Kriton Filos, Professor,MD, PhD

CONTACT

00302610999341; kritonfilos@yahoo.gr

Athina Siampalioti, MD

CONTACT

6944678681; atenaba@in.gr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 19, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 20, 2011

Record last verified: 2010-03

Locations

GR (1)