Otolaryngeal Cancer Clinical Trial
Official title:
A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
| Verified date | July 2021 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
| Status | Terminated |
| Enrollment | 71 |
| Est. completion date | April 24, 2020 |
| Est. primary completion date | February 24, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia - Competent to provide informed consent Exclusion Criteria: - Emergency surgery - Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia) - Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement - Poor health literacy - Allergy, or have experienced any drug reaction to ketamine - Pregnant or lactating - Currently in active alcohol withdrawal - Taking buprenorphine for chronic pain |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University Hospital Midtown | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame. | Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours) | |
| Secondary | Change in Behavioral Pain Scale (Non-Intubated) Score | The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain). | Post Operation (Up to 6 Hours), Post Operation Day 0 | |
| Secondary | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Scores range from 0 (no pain) to 10 (worst pain). | Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks) | |
| Secondary | Change in Mini Cog Score | The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia. | Baseline, Post Surgery (Up to 6 Weeks) | |
| Secondary | Change in Mini-Mental Status Examination (MMSE) Score | The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment. | Baseline, Post Surgery (Up to 6 Weeks) | |
| Secondary | Change in Cognitive Failure Questionnaire (CFQ) Score | The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention. | Baseline, Post Surgery (Up to 6 Weeks) | |
| Secondary | Post Operative Narcotics Use | The total amount of narcotics used measured in morphine milligram equivalents (MME). | Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention) | |
| Secondary | Associations of Intraoperative EEG Patterns With PACU Delirium | The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown. | Intraoperative EEG and delirium during PACU stay |