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Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

Primary Purpose

Morbid Obesity

Status

Unknown status

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Sevoflurane

Propofol- Remifentanyl

Propofol, Remifentanyl

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Sevoflurane, Propofol, Remifentanyl, BIS, Cardiovascular stability, Recovery scores, Drug consumption

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

SEVO group

SEVO-BIS group

Propo- Remi group

Propo-Remi-BIS group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Drug Consumption, Drug Cost.

Full Information

NCT ID

NCT01279499

First Posted

January 11, 2011

Last Updated

January 19, 2011

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01279499

Brief Title

Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Patras

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SEVO group

Arm Type

Active Comparator

Arm Description

Arm Title

SEVO-BIS group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Propo- Remi group

Arm Type

Active Comparator

Arm Description

Arm Title

Propo-Remi-BIS group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Other Intervention Name(s)

Sevoflurane , Abbott

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Other Intervention Name(s)

Sevoflurane, Abbott and BIS, Aspect Medical Systems, USA

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol- Remifentanyl

Other Intervention Name(s)

Propofol, Diprivan, Fresenius, Remifentanyl, Ultiva, GlaxoSmithKline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol, Remifentanyl

Other Intervention Name(s)

Propofol, Fresenius, BIS, Aspect Medical Systems, USA

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Drug Consumption, Drug Cost.

Time Frame

End of the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kriton Filos, Professor,MD, PhD

Phone

00302610999341

kritonfilos@yahoo.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Athina Siampalioti, MD

Phone

6944678681

atenaba@in.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Athina Siampalioth, MD

Organizational Affiliation

University of Patras, Departement of Anesthesiology and Critical Care Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kriton Filos, Professor, MD, PhD

Organizational Affiliation

University of Patras, Departement of Anesthesiology and Critical Care Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Patras

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kriton Filos, Professor

Phone

00302610999341

kritonfilos@yahoo.gr

12. IPD Sharing Statement

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