Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-01 @ 3:51 AM
Study NCT ID:
NCT06846333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid-free Anesthesia and Quality of Recovery After General Anesthesia
Sponsor:
Selcuk University
Organization:
Study Overview
Official Title:
Effect of Opioid-free Anesthesia Protocol on Quality of Recovery After Major Surgery in Geriatric Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the effect of an opioid-free anesthesia protocol on postoperative recovery quality in patients aged 65 years and older undergoing major surgery. Recovery quality was assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Findings are expected to contribute to optimizing anesthesia practices in the elderly population by improving recovery quality and reducing opioid-related side effects.
Detailed Description:
This prospective observational study aims to evaluate the impact of an opioid-free anesthesia (OFA) protocol on postoperative recovery quality in geriatric patients aged 65 years and older undergoing major non-cardiac surgery. Recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24, 48, and 72 hours postoperatively. Secondary outcomes include postoperative pain intensity (measured via VAS), opioid consumption (measured through patient-controlled analgesia devices), the incidence of postoperative cognitive dysfunction (POCD) assessed using the Mini-Mental Test (MMT) and the Clock Drawing Test, and the frequency of opioid-related adverse events (nausea, vomiting, constipation, urinary retention, dizziness, and others). Furthermore, intraoperative hemodynamic stability, extubation time, time to spontaneous ventilation recovery, and lengths of stay in the post-anesthesia care unit (PACU) and the hospital will also be recorded.
The rationale for this study is rooted in the significant side effects of opioids, such as postoperative nausea and vomiting (PONV), hyperalgesia, sedation, and respiratory depression, which can prolong recovery time and hospital discharge. To accelerate postoperative recovery and minimize opioid-related side effects, "Enhanced Recovery After Surgery (ERAS)" protocols, which have gained popularity in recent years, include OFA as an alternative analgesic strategy. OFA protocols provide multimodal analgesia through non-opioid drugs and techniques targeting various pain pathways, potentially reducing the incidence of chronic pain and expediting recovery.
A key component of the OFA protocol used in this study is ketamine, which has shown efficacy in reducing neuroinflammation and improving cognitive function, making it particularly relevant in the elderly population at risk of postoperative cognitive dysfunction. While evidence supporting the benefits of OFA in various surgical fields such as gynecology, orthopedics, and gastrointestinal surgeries is growing, there remains a lack of data on its effects on recovery outcomes in geriatric patients undergoing major surgeries. This study aims to address this gap by providing comprehensive data on the impact of OFA on recovery quality, opioid-related adverse events, and perioperative outcomes in this vulnerable population.
Patients will be divided into two groups based on the anesthesiologist's clinical preference:
1. Opioid-Based Anesthesia (Group 1): Induction with propofol, fentanyl, and rocuronium; maintenance with remifentanil and sevoflurane.
2. Opioid-Free Anesthesia (Group 2): Induction with propofol, ketamine, and rocuronium; maintenance with ketamine and propofol infusions, along with sevoflurane.
Both groups will undergo standard perioperative monitoring, including BIS (bispectral index) for anesthesia depth and continuous hemodynamic monitoring. Recovery parameters such as extubation time, spontaneous ventilation recovery, and PACU length of stay will be recorded in detail. Postoperatively, the QoR-15 questionnaire will be completed at 24, 48, and 72 hours, with follow-up by telephone for patients discharged early.
This study is expected to contribute to the limited literature on the application of OFA in geriatric surgical patients. By highlighting the potential benefits of OFA in enhancing postoperative recovery, reducing opioid consumption, and preventing opioid-related adverse events, this research aims to provide insights for safer and more effective anesthesia practices in the elderly population.
The rationale for this study is rooted in the significant side effects of opioids, such as postoperative nausea and vomiting (PONV), hyperalgesia, sedation, and respiratory depression, which can prolong recovery time and hospital discharge. To accelerate postoperative recovery and minimize opioid-related side effects, "Enhanced Recovery After Surgery (ERAS)" protocols, which have gained popularity in recent years, include OFA as an alternative analgesic strategy. OFA protocols provide multimodal analgesia through non-opioid drugs and techniques targeting various pain pathways, potentially reducing the incidence of chronic pain and expediting recovery.
A key component of the OFA protocol used in this study is ketamine, which has shown efficacy in reducing neuroinflammation and improving cognitive function, making it particularly relevant in the elderly population at risk of postoperative cognitive dysfunction. While evidence supporting the benefits of OFA in various surgical fields such as gynecology, orthopedics, and gastrointestinal surgeries is growing, there remains a lack of data on its effects on recovery outcomes in geriatric patients undergoing major surgeries. This study aims to address this gap by providing comprehensive data on the impact of OFA on recovery quality, opioid-related adverse events, and perioperative outcomes in this vulnerable population.
Patients will be divided into two groups based on the anesthesiologist's clinical preference:
1. Opioid-Based Anesthesia (Group 1): Induction with propofol, fentanyl, and rocuronium; maintenance with remifentanil and sevoflurane.
2. Opioid-Free Anesthesia (Group 2): Induction with propofol, ketamine, and rocuronium; maintenance with ketamine and propofol infusions, along with sevoflurane.
Both groups will undergo standard perioperative monitoring, including BIS (bispectral index) for anesthesia depth and continuous hemodynamic monitoring. Recovery parameters such as extubation time, spontaneous ventilation recovery, and PACU length of stay will be recorded in detail. Postoperatively, the QoR-15 questionnaire will be completed at 24, 48, and 72 hours, with follow-up by telephone for patients discharged early.
This study is expected to contribute to the limited literature on the application of OFA in geriatric surgical patients. By highlighting the potential benefits of OFA in enhancing postoperative recovery, reducing opioid consumption, and preventing opioid-related adverse events, this research aims to provide insights for safer and more effective anesthesia practices in the elderly population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: