Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447105
• Other study ID #: 2003-177-1113
• Status: Completed
• Phase: N/A
• Start date: June 28, 2020
• Est. completion date: July 27, 2021

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 27, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative nausea and vomiting during the first 24 hours postoperatively	Incidence of postoperative nausea and vomiting (%)	during the first 24 hours postoperatively
Secondary	Postoperative nausea and vomiting during the 24-48 hours postoperatively	Incidence of postoperative nausea and vomiting (%)	during the 24-48 hours postoperatively
Secondary	Postoperative nausea and vomiting during the 48-72 hours postoperatively	Incidence of postoperative nausea and vomiting (%)	during the 48-72 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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