Morbid Obesity
Conditions
Keywords
Morbid obesity, Sevoflurane, Propofol, Remifentanyl, BIS, Cardiovascular stability, Recovery scores, Drug consumption
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.
Interventions
DRUGSevoflurane
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
DRUGPropofol- 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
DRUGPropofol, 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
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Drug Consumption, Drug Cost. | End of the surgery |
Countries
Greece
Contacts
Primary ContactKriton Filos, Professor,MD, PhD
Backup ContactAthina Siampalioti, MD
Outcome results
None listed