The Influence of Induction Anesthetic Agents on Serum Cortisol Concentration in Morbidly Obese Patients.

NCT01930019 | Completed

• 1 other identifier: 06101968-2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

etomidate,; thiopental,; serum cortisol concentration,

Outcome Measures

Primary Outcomes (1)

• Serum cortisol concentration

  48 hrs

Study Arms (4)

OE

EXPERIMENTAL

OE - obese patients (BMI\>40) in which etomidate was used,

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,

Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)

OT

EXPERIMENTAL

OT - obese patients in which thiopental was used,

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

Drug: Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)

Interventions

Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental) DRUG

NE; NT; OE; OT

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• healthy patients in American Society of Anesthesiologists (ASA) class I and II awaiting elective abdominal laparoscopic surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

Obesity

Interventions

Etomidate; Thiopental

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines

Study Officials

• Marcin Możański, MD, PhD

  Department of Anesthesiology and Intensive Therapy, Military Institute of Medicine, Warsaw, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: June 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

PL (1)