The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl

This study has been withdrawn prior to enrollment.
(Change in personnel)
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01825083
First received: January 31, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

Procedures performed under sedation have the same severity in regards to morbidity and mortality as procedures performed under general anesthesia1. The demand for anesthesia care outside the operating room has increased tremendously and it poses, according to a closed claim analysis, major risks to patients. Both closed claim analysis identified respiratory depression due to over sedation as the main risk to patients undergoing procedures under sedation. The major problem is that hypoventilation is only detected at very late stages in patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation, hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.

The incidence of anesthetized patients with obstructive sleep apnea has increased substantially over the last years along with the current national obesity epidemic. These patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The context of the massive increase in procedural sedation and the extremely high prevalence of obstructive sleep apnea poses major respiratory risks to patients and it may, in a near future, increase malpractice claims to anesthesiologists. The development of safer anesthesia regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen for sedation is in direct relationship with the anesthesia patient safety foundation priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also be broadly applicable and easily implemented into daily clinical care. Ketamine has an established effect on analgesia but the effects of ketamine on ventilation have not been clearly defined. The investigators have demonstrated that the transcutaneous carbon dioxide monitor is accurate in detecting hypoventilation in patients undergoing deep sedation. Animal data suggest that when added to propofol in a sedation regimen, ketamine decreased hypoventilation when compared to propofol alone. It is unknown if ketamine added to a commonly used sedative agent (propofol) and fentanyl can decrease the incidence and severity of hypoventilation in patients undergoing deep sedation.

The investigators hypothesize that patients receiving ketamine, propofol and fentanyl will develop less intraoperative hypoventilation than patients receiving propofol and fentanyl.

The investigators also hypothesize that this effect will be even greater in patients with obstructive sleep apnea than patients without obstructive sleep apnea.

Significance: Respiratory depression due to over sedation was identified twice as the major factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep apnea combined with more complex procedures done in outpatient settings can increase physical risks to patients and liability cases to anesthesiologists. The main goal of this project is to establish the effect of ketamine in preventing respiratory depression to patients undergoing procedures under deep sedation using propofol and fentanyl.

If the investigators can confirm our hypothesis, our findings can be valuable not only to anesthesiologist but also to other specialties (emergency medicine, gastroenterologists, cardiologists, radiologists) that frequently performed procedural sedation.

The research questions is; does the addition of ketamine prevent hypoventilation during deep sedation using propofol and fentanyl?

The hypotheses of this study: Ketamine will prevent hypoventilation during deep sedation cases.


Condition Intervention
Hypercarbia
Drug: Ketamine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The total percentage time patients hypoventilate during the case [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    The total percentage time patients hypoventilate during the case


Enrollment: 0
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
Ketamine administered 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
Drug: Ketamine
Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
Other Name: Ketamine adminstration
Placebo Comparator: Placebo
Saline group will received the same volume in saline as the ketamine dose
Drug: Placebo
0.9 % normal saline group receives same volume as the ketamine dose
Other Name: 0.9 % normal saline group receives same volume as ketamine dose

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I and II

  • Age 18-64
  • Females undergoing sedation procedures

Exclusion Criteria:

  • Pregnant subjects
  • Breastfeeding
  • Patients or surgeon request
  • Difficult airway

Drop Out:

  • Patient or surgeon request
  • Conversion to general anesthesia .Inability to obtain data from CO2 monitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825083

Locations
United States, Illinois
Prentice Womens Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, MD,MS Northwestern University
  More Information

No publications provided

Responsible Party: Gildasio De Oliveira, Prinipal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01825083     History of Changes
Other Study ID Numbers: STU00068533
Study First Received: January 31, 2013
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Northwestern University:
Hypercarbia
TOSCA monitor
Ketamine
Fentanyl
Intraoperative monitoring

Additional relevant MeSH terms:
Hypoventilation
Hypercapnia
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fentanyl
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014