Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

Not Applicable

Completed

• Conditions: Enhanced Recovery After Surgery
• Interventions: Drug: total intravenous anesthesia with propofol; Drug: inhalation anesthesia with desflurane

• Registration Number: NCT04447105
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Study Start: 2020-06-28
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA group	total intravenous anesthesia with propofol	Patients receiving total intravenous anesthesia with propofol.
Desflurane group	inhalation anesthesia with desflurane	Patients receiving inhalation anesthesia with desflurane.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Postoperative nausea and vomiting during the first 24 hours postoperatively	during the first 24 hours postoperatively	Incidence of postoperative nausea and vomiting (%)
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 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
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
Postoperative nausea and vomiting during the 24-48 hours postoperatively	during the 24-48 hours postoperatively	Incidence of postoperative nausea and vomiting (%)
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of