The Influence of Induction Anesthetic Agents on Serum Cortisol Concentration in Morbidly Obese Patients.
Information source: Military Institute of Medicine, Poland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Military Institute of Medicine, Poland Official(s) and/or principal investigator(s): Marcin Możański, MD, PhD, Study Chair, Affiliation: Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine, Warsaw, Poland
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. 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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Serum cortisol concentration
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 62 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy patients in American Society of Anesthesiologists (ASA) class I and II
awaiting elective abdominal laparoscopic surgery.
Exclusion Criteria:
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.
Locations and Contacts
Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine, Warsaw 04-141, Poland
Additional Information
Starting date: June 2009
Last updated: August 27, 2013
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