Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04447105

Collaborator

(none)

150

Enrollment

Location

Arms

12.9

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery	Drug: total intravenous anesthesia with propofol Drug: inhalation anesthesia with desflurane	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective randomized single-blinded studyA prospective randomized single-blinded study

Masking:

Single (Participant)

Masking Description:

Patients will receive general anesthesia, therefore they can not know their anesthetic method. Physicians involved in this study will investigate the outcomes.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 28, 2020

Actual Primary Completion Date :

Jul 5, 2021

Actual Study Completion Date :

Jul 27, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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 (%)
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	KS013

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Hojin Lee, MD, Assistant professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04447105

Other Study ID Numbers:

2003-177-1113

First Posted:

Jun 25, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hojin Lee, MD, Assistant professor, Seoul National University Hospital

quality of recovery after surgery

anesthetic method

Additional relevant MeSH terms:

Anesthetics

Propofol

Desflurane

Study Results

No Results Posted as of Aug 5, 2021