Clinical trial · Interventional
Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Halted due to COVID 19; we believe we have adequate data for analysis
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Otolaryngeal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electroencephalogram (EEG) | Device | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ketamine 0.5 mg/kg
- description
- Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
- interventionNames
- Drug: Ketamine
- Device: Electroencephalogram (EEG)
- type
- EXPERIMENTAL
- label
- Ketamine 1.0 mg/kg
- description
- Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
- interventionNames
- Drug: Ketamine
- Device: Electroencephalogram (EEG)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available