Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients

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

Patrocinadores

Patrocinador principal: University of Patras

Fuente University of Patras
Resumen breve

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.

Descripción detallada

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.

Estado general Unknown status
Fecha de inicio April 2010
Fecha de Terminación July 2011
Fecha de finalización primaria June 2011
Fase Phase 2/Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
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
Resultado secundario
Medida Periodo de tiempo
Drug Consumption, Drug Cost. End of the surgery
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Sevoflurane

Descripción: 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

Etiqueta de grupo de brazo: SEVO group

Otro nombre: Sevoflurane , Abbott

Tipo de intervención: Drug

Nombre de intervención: Sevoflurane

Descripción: 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.

Etiqueta de grupo de brazo: SEVO-BIS group

Otro nombre: Sevoflurane, Abbott and BIS, Aspect Medical Systems, USA

Tipo de intervención: Drug

Nombre de intervención: Propofol- Remifentanyl

Descripción: 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

Etiqueta de grupo de brazo: Propo- Remi group

Tipo de intervención: Drug

Nombre de intervención: Propofol, Remifentanyl

Descripción: 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

Etiqueta de grupo de brazo: Propo-Remi-BIS group

Otro nombre: Propofol, Fresenius, BIS, Aspect Medical Systems, USA

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 50 Years

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Kriton Filos, Professor,MD, PhD

Teléfono: 00302610999341

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine Kriton Filos, Professor 00302610999341 [email protected]
Ubicacion Paises

Greece

Fecha de verificación

March 2010

Fiesta responsable

Nombre Titulo: Kriton Filos

Organización: University of Patras, Departement of Anesthesiology and Critical Care Medicine

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: SEVO group

Tipo: Active Comparator

Descripción: 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.

Etiqueta: SEVO-BIS group

Tipo: Active Comparator

Descripción: 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.

Etiqueta: Propo- Remi group

Tipo: Active Comparator

Descripción: 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.

Etiqueta: Propo-Remi-BIS group

Tipo: Active Comparator

Descripción: 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.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Triple (Participant, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov