Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

NCT ID: NCT01279499

Last Updated: 2011-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-07-31

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Propofol- Remifentanyl

Intervention Type: 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 (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

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.

Group Type: ACTIVE_COMPARATOR

Propofol, Remifentanyl

Intervention Type: 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

Interventions

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Sevoflurane , Abbott; Sevoflurane, Abbott and BIS, Aspect Medical Systems, USA; Propofol, Diprivan, Fresenius; Remifentanyl, Ultiva, GlaxoSmithKline; Propofol, Fresenius, BIS, Aspect Medical Systems, USA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

University of Patras, Departement of Anesthesiology and Critical Care Medicine

Principal Investigators

Athina Siampalioth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Patras, Departement of Anesthesiology and Critical Care Medicine

Kriton Filos, Professor, MD, PhD

Role: STUDY_CHAIR

University of Patras, Departement of Anesthesiology and Critical Care Medicine

Locations

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

Pátrai, Achaia, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Kriton Filos, Professor,MD, PhD

Role: CONTACT

kritonfilos@yahoo.gr

00302610999341

Athina Siampalioti, MD

Role: CONTACT

atenaba@in.gr

6944678681

Facility Contacts

Kriton Filos, Professor

Role: primary

kritonfilos@yahoo.gr

00302610999341

Other Identifiers

sevoflurane-propofol-obesity

Identifier Type: -

Identifier Source: org_study_id