Morbid ObesityPhase 2/3NCT01279499
Sevoflurane Versus Intravenous Anaesthetic Agents in Morbid Obese Patients
A Phase 2/3 study testing Sevoflurane, Propofol- Remifentanyl and Propofol, Remifentanyl in people with Morbid Obesity, run by University of Patras at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Sevoflurane, Propofol- Remifentanyl and Propofol, Remifentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 yrs
- BMI>50 kg/m2
- Written consent for the participation in the study
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine
Pátrai, Achaia, 26500
Kriton Filos, Professor, 00302610999341, kritonfilos@yahoo.gr
About this study
Official title: Propofol Versus Sevoflurane as Sole Anesthetic Agent in Gastric By-Pass Surgery for Morbid Obesity: A Prospective Randomized Clinical Trial
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.
Read the 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
- Being tested
- Sevoflurane, Propofol- Remifentanyl, Propofol, Remifentanyl
- Keywords
- Morbid obesity, Sevoflurane, Propofol, Remifentanyl, BIS, Cardiovascular stability, Recovery scores, Drug consumption
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevoflurane , Abbott
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
SevofluraneDrug
Also called Sevoflurane, Abbott and BIS, Aspect Medical Systems, USA
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- RemifentanylDrug
Also called Propofol, Diprivan, Fresenius, Remifentanyl, Ultiva, GlaxoSmithKline
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, RemifentanylDrug
Also called Propofol, Fresenius, BIS, Aspect Medical Systems, USA
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
| Study group | Role | What they receive |
|---|---|---|
| SEVO group | Active comparator | 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. Receives: Drug: Sevoflurane |
| SEVO-BIS group | Active comparator | 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. Receives: Drug: Sevoflurane |
| Propo- Remi group | Active comparator | 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. Receives: Drug: Propofol- Remifentanyl |
| Propo-Remi-BIS group | Active comparator | 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. Receives: Drug: Propofol, Remifentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of perioperative haemodynamic measurements (HR, MAP), recovery scores (Aldrete, White,Chung)
Measured: 5 min after induction, 1 hour after induction, end of the surgery, 2 hours postoperatively
Secondary outcomes (1)
Drug Consumption, Drug Cost.
Measured: End of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startApr 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Investigators
- Athina Siampalioth, MD, Principal investigator, University of Patras, Departement of Anesthesiology and Critical Care MedicineKriton Filos, Professor, MD, PhD, Study chair, University of Patras, Departement of Anesthesiology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279499
- Sponsor's protocol ID
- sevoflurane-propofol-obesity
- Status last verified
- Mar 2010
- First submitted
- 11 Jan 2011
- Last updated
- 20 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Sevoflurane as Sole Anesthetic Agent in Gastric By-Pass Surgery for Morbid Obesity: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01279499
- Acronym / sponsor ID
- sevoflurane-propofol-obesity
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Sevoflurane, Propofol, Remifentanyl, BIS, Cardiovascular stability, Recovery scores, Drug consumption
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SEVO group | Active comparator | Drug: SevofluraneAnaesthesia 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. |
| SEVO-BIS group | Active comparator | Drug: SevofluraneAnaesthesia 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. |
| Propo- Remi group | Active comparator | Drug: Propofol- RemifentanylGeneral 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. |
| Propo-Remi-BIS group | Active comparator | Drug: Propofol, RemifentanylGeneral 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50 yrs
- BMI>50 kg/m2
- Written consent for the participation in the study
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Sevoflurane , AbbottIntraoperatively 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 | Drug | SEVO group |
| SevofluraneAlso: Sevoflurane, Abbott and BIS, Aspect Medical Systems, USAIntraoperatively 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. | Drug | SEVO-BIS group |
| Propofol- RemifentanylAlso: Propofol, Diprivan, Fresenius, Remifentanyl, Ultiva, GlaxoSmithKlineAnaesthesia 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 | Drug | Propo- Remi group |
| Propofol, RemifentanylAlso: Propofol, Fresenius, BIS, Aspect Medical Systems, USAAnaesthesia 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 | Drug | Propo-Remi-BIS group |
Primary outcome
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
1 secondary outcome
Drug Consumption, Drug Cost.
Time frame: End of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athina Siampalioth, MD principal investigator
University of Patras, Departement of Anesthesiology and Critical Care Medicine
Kriton Filos, Professor, MD, PhD study chair
University of Patras, Departement of Anesthesiology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sevoflurane, Propofol- Remifentanyl and Propofol, Remifentanyl in people with Morbid Obesity, run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kriton Filos, Professor,MD, PhD (00302610999341, kritonfilos@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2011.