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

NCT ID: NCT01825083

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

Hypercarbia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ketamine

Ketamine administered 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.

Placebo

Saline group will received the same volume in saline as the ketamine dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9 % normal saline group receives same volume as the ketamine dose

Interventions

Ketamine

Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.

Intervention Type: DRUG

Placebo

0.9 % normal saline group receives same volume as the ketamine dose

Intervention Type: DRUG

Other Intervention Names

Ketamine adminstration; 0.9 % normal saline group receives same volume as ketamine dose

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Gildasio De Oliveira

Prinipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gildasio De Oliveira, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Prentice Womens Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00068533

Identifier Type: -

Identifier Source: org_study_id