Postoperative Quality of Recovery
Conditions
Brief summary
The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.
Interventions
COMBINATION_PRODUCTOpioid Free Total Intravenous Anesthesia
Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
COMBINATION_PRODUCTTotal Intravenous anesthesia with opioid
Total Intravenous anesthesia with opioid
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-III * Non-pregnant * Undergoing laparoscopic bariatric surgery for weight loss.
Exclusion criteria
* Unable to obtain informed consent or consent withdrawn. * Patients who are pregnant or nursing. * ASA IV-V * Alcohol or narcotic misuse or dependence in the last 2 years. * Preoperative daily opioid use for one year for pain management. * Egg or soy product allergy * Active liver disease * Patients with left ventricular assist devices * Abnormal renal function * Any contraindication to any opioid or non-opioid pain analgesics * Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | Up to two postoperative weeks | Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensities | Up to postoperative day one | Postoperative pain intensities using a 0 to 10 numerical rating scale (NRS) with higher scores indicative of higher pain intensities. |
| Opioid Consumption | Up to postoperative day one | Total postoperative opioid consumption |
| Time to Aldrete Score of 9 | Up to postoperative day one | Time to post-anesthesia care unit discharge readiness |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting | Up to postoperative day one | The incidence of any postoperative nausea, retching, or vomiting. |
Countries
United States
Outcome results
None listed