Enhanced Recovery After Surgery
Conditions
Keywords
quality of recovery after surgery, anesthetic method
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.
Interventions
In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
DRUGinhalation anesthesia with desflurane
In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will receive general anesthesia, therefore they can not know their anesthetic method. Physicians involved in this study will investigate the outcomes.
Intervention model description
A prospective randomized single-blinded study
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of recovery | at 24 hours, 48 hours, 72 hours postoperatively | Change in the QoR-15K score from 24 hours to 72 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting during the first 24 hours postoperatively | during the first 24 hours postoperatively | Incidence of postoperative nausea and vomiting (%) |
| Postoperative nausea and vomiting during the 24-48 hours postoperatively | during the 24-48 hours postoperatively | Incidence of postoperative nausea and vomiting (%) |
| Postoperative nausea and vomiting during the 48-72 hours postoperatively | during the 48-72 hours postoperatively | Incidence of postoperative nausea and vomiting (%) |
| Postoperative pain score | at 24 hours, 48 hours, 72 hours postoperatively | Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting/movement from 24 hours to 72 hours postoperatively |
| Total fentanyl consumption during the 24-48 hours postoperatively | during the 24-48 hours postoperatively | Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively |
| Total fentanyl consumption during the 48-72 hours postoperatively | during the 48-72 hours postoperatively | Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively |
| Quality of life at early post-discharge | day before surgery and at 3 weeks after discharge | Change in the Quality of life measured using the EuroQoL 5-dimension 5-level scale (EQ-5D-5L) from baseline to early-postdischarge phase |
| Total fentanyl consumption during the first 24 hours postoperatively | during the first 24 hours postoperatively | Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively |
Countries
South Korea
Outcome results
None listed