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Completed

NCT Number: NCT04447105

Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

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.

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Key information

Conditions

Enhanced Recovery After Surgery

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: DES group

Primary outcomes

  1. quality of recovery

    Time frame: at 24 hours, 48 hours, 72 hours postoperatively

    Change in the QoR-15K score from 24 hours to 72 hours postoperatively

Secondary outcomes

  1. Postoperative pain score

    Time frame: 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

  2. Postoperative nausea and vomiting during the first 24 hours postoperatively

    Time frame: during the first 24 hours postoperatively

    Incidence of postoperative nausea and vomiting (%)

  3. Postoperative nausea and vomiting during the 24-48 hours postoperatively

    Time frame: during the 24-48 hours postoperatively

    Incidence of postoperative nausea and vomiting (%)

  4. Postoperative nausea and vomiting during the 48-72 hours postoperatively

    Time frame: during the 48-72 hours postoperatively

    Incidence of postoperative nausea and vomiting (%)

  5. Total fentanyl consumption during the first 24 hours postoperatively

    Time frame: 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

  6. Total fentanyl consumption during the 24-48 hours postoperatively

    Time frame: 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

  7. Total fentanyl consumption during the 48-72 hours postoperatively

    Time frame: 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

  8. Quality of life at early post-discharge

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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