Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatment propofol
Sponsor Stanford University
Start date January 2011
End date July 2017
Trial size 40 participants
Trial identifier NCT01591148, 16509-JI, Stanford-16509

Summary

This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Morbidly obese subjects (body mass index greater than 40) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.
propofol
Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.
(Active Comparator)
Normal weight subjects (body mass index 20-25) will be given propofol during induction of general anesthesia. Plasma samples will be collected over time to ascertain propofol plasma concentration.
propofol
Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.

Primary Outcomes

Measure
plasma drug concentration of propofol
time frame: measured during the perioperative period

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - adult age (ages 18-70) - body mass index greater than 40 or between 20-25 - American Society of Anesthesiologists Class I, II, or III - undergoing elective surgical procedure requiring general anesthesia Exclusion Criteria: - evidence of cardiovascular or pulmonary disease - kidney or liver dysfunction - drug allergy to propofol - history of difficult airway - on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids - unable to speak or understand English

Additional Information

Official title A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Principal investigator Jerry Ingrande, M.D., M.S.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Stanford University.