A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects

Stanford University

Status and phase: Completed; Phase 1

Conditions: Morbid Obesity

Treatments: Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01591148

Stanford-16509

16509-JI (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Morbidly obese subjects

Experimental group

Description:

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.

Treatment:

Drug: propofol

Control subjects (body mass index 20-25)

Active Comparator group

Description:

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.

Treatment:

Drug: propofol