Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

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

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.

Study Overview

• Status: Completed
• Conditions: Enhanced Recovery After Surgery
• Intervention / Treatment: Drug: total intravenous anesthesia with propofol; Drug: inhalation anesthesia with desflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIVA group; Patients receiving total intravenous anesthesia with propofol.	Drug: total intravenous anesthesia with propofol; 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.; Other Names: TIVA group
Active Comparator: Desflurane group; Patients receiving inhalation anesthesia with desflurane.	Drug: inhalation 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.; Other Names: DES group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2020
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: quality of recovery after surgery; anesthetic method
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Desflurane
• Other Study ID Numbers: 2003-177-1113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No