Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

Seoul National University Hospital150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Enhanced Recovery After Surgery

Interventions

total intravenous anesthesia with propofolDRUG

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.

inhalation anesthesia with desfluraneDRUG

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

quality of recovery

Change in the QoR-15K score from 24 hours to 72 hours postoperatively

Time frame: at 24 hours, 48 hours, 72 hours postoperatively

Secondary Outcomes

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

Time frame: at 24 hours, 48 hours, 72 hours postoperatively

Postoperative nausea and vomiting during the first 24 hours postoperatively

Incidence of postoperative nausea and vomiting (%)

Time frame: during the first 24 hours postoperatively

Postoperative nausea and vomiting during the 24-48 hours postoperatively

Incidence of postoperative nausea and vomiting (%)

Time frame: during the 24-48 hours postoperatively

Postoperative nausea and vomiting during the 48-72 hours postoperatively

Incidence of postoperative nausea and vomiting (%)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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