Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

NCT04447105 | Completed DMC

• 1 other identifier: 2003-177-1113
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery

Keywords

quality of recovery after surgery; anesthetic method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative pain score

  at 24 hours, 48 hours, 72 hours postoperatively

• Postoperative nausea and vomiting during the first 24 hours postoperatively

  during the first 24 hours postoperatively

• Postoperative nausea and vomiting during the 24-48 hours postoperatively

  during the 24-48 hours postoperatively

• Postoperative nausea and vomiting during the 48-72 hours postoperatively

  during the 48-72 hours postoperatively

• Total fentanyl consumption during the first 24 hours postoperatively

  during the first 24 hours postoperatively

Study Arms (2)

TIVA group

EXPERIMENTAL

Patients receiving total intravenous anesthesia with propofol.

Drug: total intravenous anesthesia with propofol

Desflurane group

ACTIVE COMPARATOR

Patients receiving inhalation anesthesia with desflurane.

Drug: inhalation anesthesia with desflurane

Interventions

total intravenous anesthesia with propofol DRUG

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.

Also known as: TIVA group

TIVA group

inhalation anesthesia with desflurane DRUG

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.

Also known as: DES group

Desflurane group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

Related 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.

  PMID: 25500679 BACKGROUND

MeSH Terms

Interventions

Propofol; Anesthesia, Inhalation; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will receive general anesthesia, therefore they can not know their anesthetic method. Physicians involved in this study will investigate the outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: A prospective randomized single-blinded study

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: June 28, 2020
• Primary Completion: July 5, 2021
• Study Completion: July 27, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)