ObesityNCT01930019
The Influence of Induction Anesthetic Agents on Serum Cortisol Concentration in Morbidly Obese Patients.
A study testing Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) in people with Obesity, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
The effect of etomidate administration on the adrenal cortex in obese patients is still unclear. The objective of the study was to determine the influence of single dose of etomidate on cortisol secretion in morbidly obese. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2009to Jul 2011
- Phase
- Interventional
- 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 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- healthy patients in American Society of Anesthesiologists (ASA) class I and II awaiting elective abdominal laparoscopic surgery.
Who cannot join
- The patients, who
- did not agree to participate,
- were treated with steroidal drugs,
- had cortisol metabolism disorders or were treated with drugs with a potential impact on serum cortisol concentration,
- had a preoperative risk assessment result of ASA class III, IV and V,
- had an initial surgical laparoscopic technique converted to laparotomy, and
- had surgical complications increasing the level of intraoperative stress.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine
Warsaw, 04-141
About this study
Official title: The Influence of Induction Agents of General Anesthesia (Etomidate and Thiopental) on Serum Cortisol Concentration in Morbidly Obese Patients. A Randomized Controlled Trial.
The effect of etomidate administration on the adrenal cortex in obese patients is still unclear. The objective of the study was to determine the influence of single dose of etomidate on cortisol secretion in morbidly obese. The participants were divided equally into etomidate and thiopental groups, depending on kind of intravenous anesthetic used for induction of anesthesia.
Healthy patients in ASA class I and II awaiting elective abdominal laparoscopic surgery were included in the study. The participants were initially divided into two groups: the first group included patients with morbid obesity (BMI > 40), and the second group included patients with normal body weight (BMI < 25). All the patients inside the two groups were subsequently randomly and divided into etomidate and thiopental groups, according to the intravenous anesthetic used as the induction agent for general anesthesia. Finally, four groups of patients were analyzed: 1. obese, in which etomidate was used (OE group), 2. obese, in which thiopental was used (OT group), 3. patients with normal body mass, in which etomidate was used (NE group), and 4. patients with normal body mass, in which thiopental was used (NT group).
The patients excluded from the study were those who: 1. did not agree to participate, 2. were treated with steroidal drugs, 3. had cortisol metabolism disorders or were treated with drugs with a potential impact on serum cortisol concentration, 4. had a preoperative risk assessment result of ASA class III, IV and V, 5. had an initial surgical laparoscopic technique converted to laparotomy, and 6. had surgical complications increasing the level of intraoperative stress.
Read the detailed description
One hour before the induction of general anesthesia midazolam was administered orally as a premedication. After the patient's arrival in the operating theater, standard monitoring was commenced. All the patients were oxygenated. Depending on the study group, either etomidate or thiopental was used as an induction agent for general anesthesia. Both anesthetics were administered according to ideal body weight. When the ciliary reflex disappeared, either suxamethonium chloride or rocuronium bromide was administered, depending on the possible problems in endotracheal intubation. The general anesthesia was maintained with desflurane, continuous intravenous infusion of remifentanil, and repeated doses of rocuronium bromide as required.
Each patient had their serum cortisol concentration level measured five times. The first measure was taken the afternoon of the day before surgery (A sample), and the second two hours after induction of anesthesia with etomidate or thiopental (B sample). Subsequently a short stimulation test with intravenous injection of 250 μg of tetracosactide, a synthetic analogue of adrenocorticotropic hormone (ACTH), was performed. The third sample was taken thirty minutes after the short stimulation test blood (C sample), and next, the fourth (D) sample was taken 24 hours after induction of anesthesia. Immediately afterwards, a second short stimulation test with 250 μg of tetracosactide was performed, and 30 minutes later, the fifth blood sample (E sample) was taken.
The serum cortisol concentration was measured by electrochemiluminescence.
The patients' participation of the study ended when the last, fifth blood sample was withdrawn.
- Conditions
- Obesity
- Being tested
- Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)
- Keywords
- etomidate,, thiopental,, serum cortisol concentration,
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)Drug
| Study group | Role | What they receive |
|---|---|---|
| OE | Experimental | OE - obese patients (BMI>40) in which etomidate was used, Receives: Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) |
| NE | Other | NE - patients with normal body mass (BMI<25), in which etomidate was used, Receives: Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) |
| OT | Experimental | OT - obese patients in which thiopental was used, Receives: Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) |
| NT | Other | NT - patients with normal body mass, in which thiopental was used Receives: Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol concentration
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dariusz Tomaszewski, Military Institute od Medicine National Research Institute
- Investigators
- Marcin Możański, MD, PhD, Study chair, Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930019
- Sponsor's protocol ID
- 06101968-2
- Status last verified
- Aug 2013
- First submitted
- 23 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Induction Agents of General Anesthesia (Etomidate and Thiopental) on Serum Cortisol Concentration in Morbidly Obese Patients. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01930019
- Acronym / sponsor ID
- 06101968-2
- Conditions
- Obesity
- Keywords
- etomidate,, thiopental,, serum cortisol concentration,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Aug 2013 (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 effect of etomidate administration on the adrenal cortex in obese patients is still unclear. The objective of the study was to determine the influence of single dose of etomidate on cortisol secretion in morbidly obese. The participants were divided equally into etomidate and thiopental groups, depending on kind of intravenous anesthetic used for induction of anesthesia.
Healthy patients in ASA class I and II awaiting elective abdominal laparoscopic surgery were included in the study. The participants were initially divided into two groups: the first group included patients with morbid obesity (BMI > 40), and the second group included patients with normal body weight (BMI < 25). All the patients inside the two groups were subsequently randomly and divided into etomidate and thiopental groups, according to the intravenous anesthetic used as the induction agent for general anesthesia. Finally, four groups of patients were analyzed: 1. obese, in which etomidate was used (OE group), 2. obese, in which thiopental was used (OT group), 3. patients with normal body mass, in which etomidate was used (NE group), and 4. patients with normal body mass, in which thiopental was used (NT group).
The patients excluded from the study were those who: 1. did not agree to participate, 2. were treated with steroidal drugs, 3. had cortisol metabolism disorders or were treated with drugs with a potential impact on serum cortisol concentration, 4. had a preoperative risk assessment result of ASA class III, IV and V, 5. had an initial surgical laparoscopic technique converted to laparotomy, and 6. had surgical complications increasing the level of intraoperative stress.
Detailed description
One hour before the induction of general anesthesia midazolam was administered orally as a premedication. After the patient's arrival in the operating theater, standard monitoring was commenced. All the patients were oxygenated. Depending on the study group, either etomidate or thiopental was used as an induction agent for general anesthesia. Both anesthetics were administered according to ideal body weight. When the ciliary reflex disappeared, either suxamethonium chloride or rocuronium bromide was administered, depending on the possible problems in endotracheal intubation. The general anesthesia was maintained with desflurane, continuous intravenous infusion of remifentanil, and repeated doses of rocuronium bromide as required.
Each patient had their serum cortisol concentration level measured five times. The first measure was taken the afternoon of the day before surgery (A sample), and the second two hours after induction of anesthesia with etomidate or thiopental (B sample). Subsequently a short stimulation test with intravenous injection of 250 μg of tetracosactide, a synthetic analogue of adrenocorticotropic hormone (ACTH), was performed. The third sample was taken thirty minutes after the short stimulation test blood (C sample), and next, the fourth (D) sample was taken 24 hours after induction of anesthesia. Immediately afterwards, a second short stimulation test with 250 μg of tetracosactide was performed, and 30 minutes later, the fifth blood sample (E sample) was taken.
The serum cortisol concentration was measured by electrochemiluminescence.
The patients' participation of the study ended when the last, fifth blood sample was withdrawn.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OE | Experimental | Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)OE - obese patients (BMI>40) in which etomidate was used, |
| NE | Other | Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)NE - patients with normal body mass (BMI<25), in which etomidate was used, |
| OT | Experimental | Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)OT - obese patients in which thiopental was used, |
| NT | Other | Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)NT - patients with normal body mass, in which thiopental was used |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy patients in American Society of Anesthesiologists (ASA) class I and II awaiting elective abdominal laparoscopic surgery.
Key exclusion criteria (7 listed)
- The patients, who
- did not agree to participate,
- were treated with steroidal drugs,
- had cortisol metabolism disorders or were treated with drugs with a potential impact on serum cortisol concentration,
- had a preoperative risk assessment result of ASA class III, IV and V,
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 |
|---|---|---|
| Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) | Drug | NE, NT, OE, OT |
Primary outcome
Serum cortisol concentration
Time frame: 48 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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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.
Marcin Możański, MD, PhD study chair
Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) in people with Obesity, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 28 Aug 2013. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cortisol concentration (time frame: 48 hrs). 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 28 Aug 2013.