Analysis of Autonomic Function During Anesthesia Using Response Surface Model

NCT03072069 | Completed DMC

• 1 other identifier: NationalCentralU-RSM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it is important to understand the interaction pharmacodynamics of these agents as they are used clinically. A good method for visualizing the pharmacodynamic interaction behavior of drug combinations is through response surface models. Unlike traditional isobolograms that represent the concentrations of two agents that combine to produce a single degree of drug effect, response surface models characterize the complete spectrum of interaction between two or more agents for all possible levels of concentration and effect. The investigators try to use the response surface model to evaluate the effect of anesthetic combination of autonomic system.

Conditions

Anesthesia; Reaction; Autonomic Imbalance

Outcome Measures

Primary Outcomes (1)

• change of heart rate variability

  propofol anesthesia or combination with other anesthetics would affect HRV depending on the concentrations

  up to 24 weeks

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A prospective, observational, non-randomized study was conducted in 30 patients with American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery. Participants ages ranged from 20 to 60 years. Exclusion criteria were recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.

You may qualify if:

• American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery.

You may not qualify if:

• recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.

Sponsors & Collaborators

• National Central University: lead

Study Sites (1)

Department of Surgery, Hsin-chu Branch, Taipei Veterans General Hospital, Taiwan

Hsinchu, 320, Taiwan

Location

Study Officials

• Chien-Kun Ting, PhD

  National Yang Ming Chiao Tung University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 7, 2017
• Study Start: February 21, 2017
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

TW (1)