Clinical trial NCT04447105: Comparison of Postoperative Recovery Between TIVA and Inhalation Agent
Official title: Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Surgery
Keywords: quality of recovery after surgery
anesthetic method
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized single-blinded study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: quality of recovery
timeFrame: at 24 hours, 48 hours, 72 hours postoperatively
Secondary outcomes:
measure: Postoperative pain score
timeFrame: at 24 hours, 48 hours, 72 hours postoperatively
measure: Postoperative nausea and vomiting during the first 24 hours postoperatively
timeFrame: during the first 24 hours postoperatively
measure: Postoperative nausea and vomiting during the 24-48 hours postoperatively
timeFrame: during the 24-48 hours postoperatively
measure: Postoperative nausea and vomiting during the 48-72 hours postoperatively
timeFrame: during the 48-72 hours postoperatively
measure: Total fentanyl consumption during the first 24 hours postoperatively
timeFrame: during the first 24 hours postoperatively
measure: Total fentanyl consumption during the 24-48 hours postoperatively
timeFrame: during the 24-48 hours postoperatively
measure: Total fentanyl consumption during the 48-72 hours postoperatively
timeFrame: during the 48-72 hours postoperatively
measure: Quality of life at early post-discharge
timeFrame: day before surgery and at 3 weeks after discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.