Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)

Conditions
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Enhanced Recovery After Surgery

Intervention / Treatment
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* Drug: total intravenous anesthesia with propofol
* Drug: inhalation anesthesia with desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized single-blinded study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVA group<br>Patients receiving total intravenous anesthesia with propofol. | Drug: total intravenous anesthesia with propofol<br>* 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.<br>* Other names: TIVA group;|
| Active Comparator: Desflurane group<br>Patients receiving inhalation anesthesia with desflurane. | Drug: inhalation anesthesia with desflurane<br>* 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.<br>* Other names: DES group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of recovery | Change in the QoR-15K score from 24 hours to 72 hours postoperatively | at 24 hours, 48 hours, 72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | 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 | at 24 hours, 48 hours, 72 hours postoperatively | 
| Postoperative nausea and vomiting during the first 24 hours postoperatively | Incidence of postoperative nausea and vomiting (%) | during the first 24 hours postoperatively | 
| Postoperative nausea and vomiting during the 24-48 hours postoperatively | Incidence of postoperative nausea and vomiting (%) | during the 24-48 hours postoperatively | 
| Postoperative nausea and vomiting during the 48-72 hours postoperatively | Incidence of postoperative nausea and vomiting (%) | during the 48-72 hours postoperatively | 
| Total fentanyl consumption 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 | during the first 24 hours postoperatively | 
| Total fentanyl consumption 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 | during the 24-48 hours postoperatively | 
| Total fentanyl consumption 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 | during the 48-72 hours postoperatively | 
| Quality of life at early post-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 | day before surgery and at 3 weeks after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of recovery after surgery, anesthetic method