Compare the Effect of Propofol vs. "Ketofol" on Hemodynamic Stability During Induction of General Anesthesia

NCT02282891 | Withdrawn Phase 2

• 1 other identifier: 1406014189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the hemodynamic effects of a standardized induction of general anesthesia with either propofol or ketofol in patients with physical status classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT) with two arms of treatment groups. One arm will consist of induction of general anesthesia using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose will be 1.5mg/kg of propofol and 0.75mg/kg of ketamine; the second arm will consist of induction of general anesthesia using propofol 2mg/kg. The primary outcome of the intervention will consist of hemodynamic changes during the first 30 minutes after induction of general anesthesia.

Conditions

Patients With "ASA 3" Designation

Keywords

propofol; ketofol

Outcome Measures

Primary Outcomes (1)

• Number of time points during which blood pressure was below 20% of baseline BP

  The number of time points during which the blood pressure was below 20% of the baseline BP. The first blood pressure upon arrival to the operating room before any anesthetic medications are administered will be the reference (baseline) blood pressure. BP will be measured every 1 minute from one minute before induction until 30 minutes after endotracheal intubation.

  up to 30 minutes after intubation

Secondary Outcomes (7)

• Severity of hypotension

  up to 30 minutes after intubation

• Total dosage of vasopressors administered

  up to 30 minutes after intubation

• Amount of IV fluids administered

  up to 30 minutes after intubation

• Additional Medication Usage

  up to 30 minutes after intubation

• Total Opioid Dosage Used

  up to 30 minutes after intubation

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Induction of general Anesthesia using propofol 2mg/kg

Drug: Propofol

Propofol/Ketamine (ketofol)

EXPERIMENTAL

Induction of general anesthesia using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine

Drug: Propofol-Ketamine

Interventions

Propofol DRUG

Induction of general anesthesia using propofol 2mg/kg

Also known as: Diprivan

Propofol

Propofol-Ketamine DRUG

Induction of general anesthesia using a mixture of 1.5 mg/kg:0.75 mg/kg propofol/ketamine

Also known as: ketofol

Propofol/Ketamine (ketofol)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-80 scheduled for elective surgery
• Physical status ASA 3.

You may not qualify if:

• Patients with a physical status of ASA 1,2, 4 or 5,
• Prior adverse reaction to propofol, ketamine or both

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jamel P Ortoleva, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Jean Charchaflieh, MD,MPH,DrPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)