Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)
Overview
- Phase
- N/A
- Intervention
- total intravenous anesthesia with propofol
- Conditions
- Enhanced Recovery After Surgery
- Sponsor
- Seoul National University Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- quality of recovery
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.
Detailed Description
Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.
Investigators
Hojin Lee, MD
Assistant professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical classification I-II
- •Willingness and ability to sign an informed consent document
Exclusion Criteria
- •Do not understand our study
- •American Society of Anesthesiologists (ASA) physical classification III or more
- •Allergies to anesthetic or analgesic medications
- •Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- •Medical or psychological disease that can affect the treatment response
- •Patients who receive mechanical ventilation more than 2 hours after surgery
Arms & Interventions
TIVA group
Patients receiving total intravenous anesthesia with propofol.
Intervention: total intravenous anesthesia with propofol
Desflurane group
Patients receiving inhalation anesthesia with desflurane.
Intervention: inhalation anesthesia with desflurane
Outcomes
Primary Outcomes
quality of recovery
Time Frame: at 24 hours, 48 hours, 72 hours postoperatively
Change in the QoR-15K score from 24 hours to 72 hours postoperatively
Secondary Outcomes
- Postoperative nausea and vomiting during the first 24 hours postoperatively(during the first 24 hours postoperatively)
- Postoperative pain score(at 24 hours, 48 hours, 72 hours postoperatively)
- Postoperative nausea and vomiting during the 48-72 hours postoperatively(during the 48-72 hours postoperatively)
- Total fentanyl consumption during the first 24 hours postoperatively(during the first 24 hours postoperatively)
- Quality of life at early post-discharge(day before surgery and at 3 weeks after discharge)
- Postoperative nausea and vomiting during the 24-48 hours postoperatively(during the 24-48 hours postoperatively)
- Total fentanyl consumption during the 24-48 hours postoperatively(during the 24-48 hours postoperatively)
- Total fentanyl consumption during the 48-72 hours postoperatively(during the 48-72 hours postoperatively)