Obstructive Sleep Apnea, Postoperative Complications, Sleep Apnea
Conditions
Keywords
Ketamine, Postoperative morbidity
Brief summary
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Detailed description
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.
Interventions
DRUGKetamine
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
PROCEDUREControl
OSA patients receiving standard inhaled anesthesia combined with normal saline
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 19-100 * scheduled to undergo general ENT or Orthopedic Surgery * diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).
Exclusion criteria
* positive pregnancy test * ASA \> III * history of alcohol or narcotic abuse in last 90 days * significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%) * significant psychiatric or neurologic disease * history of significant hepatic or renal disease (baseline creatinine\>1.5) * history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP * increased IOP * severe arrhythmias * history of delirium * history of hallucinations * history of psychosis * history of uncontrolled seizures * potential risk for malignant hyperthermia (family history) * history of difficult intubation that would preclude standard induction of anesthesia * prisoners * persons who are mentally impaired * non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | up to 24 hours postoperatively | Visual Analog Scale pain rating |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | At 24 hrs post-op | Patients will rate their quality of anesthesia services |
Countries
United States
Participant flow
Pre-assignment details
Three participants were excluded prior to randomization due to the following reasons: 1. The patient was experiencing on-going neurological issues and was therefore removed from the study prior to randomization. 2. The patient missed his/her own surgery date. 3. The patient ended up having outpatient surgery, and was therefore excluded.
Participants by arm
| Arm | Count |
|---|---|
| Control Group OSA patients will receive standard inhaled anesthesia with normal saline infusion
Control: OSA patients receiving standard inhaled anesthesia combined with normal saline | 2 |
| Ketamine Group OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Control Group | Ketamine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized African-American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Males | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Pain Scores
Visual Analog Scale pain rating
Time frame: up to 24 hours postoperatively
Population: Study was terminated. Data was not collected.
Secondary
Patient Satisfaction Score
Patients will rate their quality of anesthesia services
Time frame: At 24 hrs post-op
Population: Participants were not analyzed due to study being terminated. Data was not collected.