Skip to content

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

A Randomized-Controlled Trial to Compare the Effect of Propofol vs. Ketofol on Hemodynamic Stability During Induction of General Anesthesia

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02282891
Enrollment
0
Registered
2014-11-05
Start date
2015-01-31
Completion date
2016-08-31
Last updated
2016-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With ASA 3 Designation

Keywords

propofol, ketofol

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.

Detailed description

The anesthetic agent propofol can result in hypotension when used for induction of general anesthesia. Recent trials suggest that even a short duration of hypotension during induction of anesthesia can adversely affect organ function and overall outcome.1 To overcome the hypotensive effect of propofol, ketamine, which has sympathomimetic effects, has been combined with propofol to produce a mixture labeled ketofol, which has been used both for procedural sedation and induction of general anesthesia. Clinical trials have shown that ketofol can attenuate the hypotensive effects of propofol during procedural sedation or induction of general anesthesia in patients whose physical status is 1 or 2 according to the American Society of Anesthesiologists (ASA 1-2), i.e., healthy patients or those with mild-moderate systemic illness.2,3 Clinically, it is important to demonstrate the efficacy of ketofol in attenuating hypotensive effects of propofol in sicker patients, i.e., patients with physical status ASA 3. 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 propfol 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. Baseline demographics collected for each patient will include: 1. age 2. sex 3. ASA physical status 4. Hx of HTN 5. Hx of PONV 6. Preoperative pain score The standardized induction of anesthesia will consist of intravenous administration of midazolam 0.04mg/kg, lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, glycopyrrolate 0.004 mg/kg, an unlabeled pre-prepared, covered syringe which will be prepared by the Yale Anesthesia satellite pharmacist containing either propofol 2mg/kg or a mixture propofol 1.5mg/kg and ketamine 0.75mg/kg, the amount of which will be pre-determined based on the patient weight, and rocuronium 0.6 mg/kg. A backup 10cc syringe of the study drug will be available as well if the initial dose is inadequate. The choice of propofol and ketamine dosing is based on a study cited earlier by Smischney et al in 2012 that addresses ASA 1-2 patients undergoing induction of general anesthesia. Endotracheal intubation will take place after adequate muscle relaxation has been determined using fade of train of four on a nerve stimulator placed over the ulnar nerve. Additional medication to facilitate induction will be used according to the judgment of the anesthesia provider with a backup syringe of the same study drug. Inhalational anesthesia will be administered after confirmation of endotracheal intubation. Treatment of hypotension will be according to the anesthesia provider. Amounts of intravenous fluids as well as doses of vasopressor that are used during induction and in the subsequent 30 minutes after endotracheal intubation will be obtained from the anesthesia record. The first blood pressure (BP) 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. The primary outcome of the study will be the number of time points during which the blood pressure was below 20% of the baseline BP. Secondary outcomes will include: 1. Severity of hypotension as determined by the gradient of each blood pressure measurement from the baseline BP. 2. The total dosage of vasopressors administered during induction and up to 30 minutes after endotracheal intubation 3. The total amount of IV fluids administered during induction and up to 30 minutes after endotracheal intubation. 4. The total amount of additional medications used during induction and up to 30 minutes after endotracheal intubation. 5. Total intraoperative as well as postoperative opioid dosage used. 6. Presence or absence of PONV and severity 7. Intraoperative prophylaxis and postoperative treatment of PONV

Interventions

DRUGPropofol

Induction of general anesthesia using propofol 2mg/kg

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

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of time points during which blood pressure was below 20% of baseline BPup to 30 minutes after intubationThe 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.

Secondary

MeasureTime frameDescription
Total dosage of vasopressors administeredup to 30 minutes after intubationThe total dosage of vasopressors administered during induction and up to 30 minutes after endotracheal intubation
Amount of IV fluids administeredup to 30 minutes after intubationThe total amount of IV fluids administered during induction and up to 30 minutes after endotracheal intubation.
Additional Medication Usageup to 30 minutes after intubationThe total amount of additional medications used during induction and up to 30 minutes after endotracheal intubation.
Severity of hypotensionup to 30 minutes after intubationAs determined by the gradient of each blood pressure measurement from the baseline BP
Post Operative Nausea and Vomiting (PONV) Severity72 hours post surgeryPresence or absence of PONV and severity within 72 hours of surgery
Treatment of Post Operative Nausea and Vomiting (PONV)72 hours post surgeryNumber and dose of anti-emetics given within 72 hours of surgery
Total Opioid Dosage Usedup to 30 minutes after intubationTotal intraoperative as well as postoperative opioid dosage used.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026