Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

Morbid Obesity Clinical Trial

Official title:

Propofol Versus Sevoflurane as Sole Anesthetic Agent in Gastric By-Pass Surgery for Morbid Obesity: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01279499
• Other study ID #: sevoflurane-propofol-obesity
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 11, 2011
• Last updated: January 19, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2010
• Source: University of Patras
• Contact: Kriton Filos, Professor,MD, PhD
• Phone: 00302610999341
• Email: kritonfilos[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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
• 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.
• 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
• 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

Locations

Country	Name	City	State
Greece	University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Drug Consumption, Drug Cost.		End of the surgery	Yes